Trial Outcomes & Findings for Accelerated iTBS in Smoking Cessation (NCT NCT05271175)
NCT ID: NCT05271175
Last Updated: 2022-09-26
Results Overview
Τhe number of cigarettes participants usually smoke before the treatment.
COMPLETED
NA
104 participants
Baseline
2022-09-26
Participant Flow
Participant milestones
| Measure |
Active TMS & Neutral Videos
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Treatment
STARTED
|
34
|
33
|
37
|
|
Treatment
COMPLETED
|
29
|
30
|
30
|
|
Treatment
NOT COMPLETED
|
5
|
3
|
7
|
|
One Week Follow up
STARTED
|
29
|
30
|
30
|
|
One Week Follow up
COMPLETED
|
19
|
23
|
25
|
|
One Week Follow up
NOT COMPLETED
|
10
|
7
|
5
|
|
One Month Follow up
STARTED
|
29
|
30
|
30
|
|
One Month Follow up
COMPLETED
|
17
|
23
|
21
|
|
One Month Follow up
NOT COMPLETED
|
12
|
7
|
9
|
|
Six Months Follow up
STARTED
|
29
|
30
|
30
|
|
Six Months Follow up
COMPLETED
|
21
|
28
|
28
|
|
Six Months Follow up
NOT COMPLETED
|
8
|
2
|
2
|
Reasons for withdrawal
| Measure |
Active TMS & Neutral Videos
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
One Week Follow up
Lost to Follow-up
|
10
|
7
|
5
|
|
One Month Follow up
Lost to Follow-up
|
12
|
7
|
9
|
|
Six Months Follow up
Lost to Follow-up
|
8
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Types of cigarettes
Hand-rolled
|
10 Participants
n=29 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
20 Participants
n=89 Participants
|
|
Types of cigarettes
Cigarillos
|
1 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=89 Participants
|
|
Types of cigarettes
Mixed
|
2 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=89 Participants
|
|
Years of smoking
|
23.18 years
STANDARD_DEVIATION 9.82 • n=29 Participants
|
23.13 years
STANDARD_DEVIATION 13.58 • n=30 Participants
|
28.73 years
STANDARD_DEVIATION 12.21 • n=30 Participants
|
25.06 years
STANDARD_DEVIATION 12.17 • n=89 Participants
|
|
If ever quitted
No
|
9 Participants
n=29 Participants
|
10 Participants
n=30 Participants
|
11 Participants
n=30 Participants
|
30 Participants
n=89 Participants
|
|
Age, Continuous
|
46.52 years
STANDARD_DEVIATION 13.05 • n=29 Participants
|
42.93 years
STANDARD_DEVIATION 14.42 • n=30 Participants
|
47.43 years
STANDARD_DEVIATION 12.72 • n=30 Participants
|
45.62 years
STANDARD_DEVIATION 13.42 • n=89 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=29 Participants
|
10 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
29 Participants
n=89 Participants
|
|
If ever quitted
Yes
|
20 Participants
n=29 Participants
|
20 Participants
n=30 Participants
|
19 Participants
n=30 Participants
|
59 Participants
n=89 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=29 Participants
|
20 Participants
n=30 Participants
|
18 Participants
n=30 Participants
|
60 Participants
n=89 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Education
|
14.07 years
STANDARD_DEVIATION 3.95 • n=29 Participants
|
14.43 years
STANDARD_DEVIATION 3.77 • n=30 Participants
|
13.60 years
STANDARD_DEVIATION 3.27 • n=30 Participants
|
14.03 years
STANDARD_DEVIATION 3.65 • n=89 Participants
|
|
Occupation
Private employee
|
13 Participants
n=29 Participants
|
19 Participants
n=30 Participants
|
22 Participants
n=30 Participants
|
54 Participants
n=89 Participants
|
|
Occupation
Public employee
|
7 Participants
n=29 Participants
|
4 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
12 Participants
n=89 Participants
|
|
Occupation
Self-employed / freelancer
|
5 Participants
n=29 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
10 Participants
n=89 Participants
|
|
Occupation
Unemployed
|
2 Participants
n=29 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=89 Participants
|
|
Occupation
Retired
|
2 Participants
n=29 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
9 Participants
n=89 Participants
|
|
Occupation
Student
|
0 Participants
n=29 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=89 Participants
|
|
Cigarettes per day
|
27.55 cigarettes/day
STANDARD_DEVIATION 15.37 • n=29 Participants
|
26.83 cigarettes/day
STANDARD_DEVIATION 12.86 • n=30 Participants
|
30.00 cigarettes/day
STANDARD_DEVIATION 13.38 • n=30 Participants
|
28.13 cigarettes/day
STANDARD_DEVIATION 13.80 • n=89 Participants
|
|
Types of cigarettes
Normal
|
16 Participants
n=29 Participants
|
25 Participants
n=30 Participants
|
24 Participants
n=30 Participants
|
65 Participants
n=89 Participants
|
|
How many times quitted
|
0.90 quit attempts
STANDARD_DEVIATION 0.77 • n=29 Participants
|
1.00 quit attempts
STANDARD_DEVIATION 1.11 • n=30 Participants
|
1.20 quit attempts
STANDARD_DEVIATION 1.56 • n=30 Participants
|
1.03 quit attempts
STANDARD_DEVIATION 1.19 • n=89 Participants
|
PRIMARY outcome
Timeframe: BaselineΤhe number of cigarettes participants usually smoke before the treatment.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Self-reported Nicotine Consumption
|
27.55 cigarettes/day
Standard Error 15.37
|
26.83 cigarettes/day
Standard Error 12.86
|
30.00 cigarettes/day
Standard Error 13.38
|
PRIMARY outcome
Timeframe: After 1st treatment dayPopulation: Two participants from the "Active TMS \& Neutral videos" group and three participants from the "Active TMS \& Smoking videos" group were outliers and were therefore excluded from the analyses.
Participants were required to record the number of cigarettes smoked after the completion of the 1st day of treatment until before the first session on the second day of treatment. Participants were asked not to smoke during the breaks of the 4 daily rTMS sessions
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=27 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=27 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Self-reported Nicotine Consumption
|
8.72 cigarettes/day
Standard Deviation 8.97
|
8.67 cigarettes/day
Standard Deviation 8.56
|
10.60 cigarettes/day
Standard Deviation 7.49
|
PRIMARY outcome
Timeframe: After 2nd treatment dayParticipants were required to record the number of cigarettes smoked after the completion of the 2nd day of treatment until before the first session on the 3rd day of treatment. Participants were asked not to smoke during the breaks of the 4 daily rTMS sessions
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=27 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=29 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Self-reported Nicotine Consumption
|
7.94 cigarettes/day
Standard Deviation 8.13
|
7.07 cigarettes/day
Standard Deviation 6.43
|
9.38 cigarettes/day
Standard Deviation 7.90
|
PRIMARY outcome
Timeframe: After 3rd treatment dayParticipants were required to record the number of cigarettes smoked after the completion of the 3rd day of treatment until before the first session on the 4th day of treatment. Participants were asked not to smoke during the breaks of the 4 daily rTMS sessions
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=26 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=26 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Self-reported Nicotine Consumption
|
5.92 cigarettes/day
Standard Deviation 6.68
|
7.79 cigarettes/day
Standard Deviation 8.61
|
8.20 cigarettes/day
Standard Deviation 7.80
|
PRIMARY outcome
Timeframe: After 4th treatment dayParticipants were required to record the number of cigarettes smoked after the completion of the 4th day of treatment until before the first session on the 5th day of treatment . Participants were asked not to smoke during the breaks of the 4 daily rTMS sessions
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=26 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=27 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Self-reported Nicotine Consumption
|
5.27 cigarettes/day
Standard Deviation 7.51
|
4.67 cigarettes/day
Standard Deviation 6.50
|
6.27 cigarettes/day
Standard Deviation 7.84
|
PRIMARY outcome
Timeframe: BaselineCO level was measured using the piCO Smokerlyzer breath carbon monoxide meter device prior to the first rTMS session.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=28 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=29 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
|
23.64 ppm
Standard Deviation 14.68
|
17.24 ppm
Standard Deviation 10.17
|
21.13 ppm
Standard Deviation 9.63
|
PRIMARY outcome
Timeframe: Day 1The average of the four CO-levels, measured before each of the four sessions on Day 1.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
|
19.09 ppm
Standard Error 12.14
|
14.83 ppm
Standard Error 8.47
|
17.77 ppm
Standard Error 7.88
|
PRIMARY outcome
Timeframe: Day 2The average of the four CO-levels, measured before each of the four sessions on Day 2.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
|
11.09 ppm
Standard Deviation 9.69
|
9.94 ppm
Standard Deviation 8.17
|
11.03 ppm
Standard Deviation 7.50
|
PRIMARY outcome
Timeframe: Day 3The average of the four CO-levels, measured before each of the four sessions on Day 3.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
|
9.98 ppm
Standard Deviation 10.15
|
9.61 ppm
Standard Deviation 6.63
|
8.85 ppm
Standard Deviation 6.58
|
PRIMARY outcome
Timeframe: Day 4The average of the four CO-levels, measured before each of the four sessions on Day 4.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
|
8.35 ppm
Standard Deviation 8.44
|
8.58 ppm
Standard Deviation 6.65
|
8.89 ppm
Standard Deviation 6.96
|
PRIMARY outcome
Timeframe: Day 5The average of the four CO-levels, measured before each of the four sessions on Day 5.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Carbon Monoxide (CO)- Evaluated Nicotine Consumption
|
8.98 ppm
Standard Deviation 9.68
|
8.03 ppm
Standard Deviation 7.27
|
8.18 ppm
Standard Deviation 7.02
|
PRIMARY outcome
Timeframe: BaselineFagerström test for Nicotine Dependence (FTND) is a short, self-report measure that assesses nicotine dependence. It contains six questions, and the total score is calculated as a sum of these six questions. The scores vary from 0 to 10, with lower scores indicating lower dependence on nicotine.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Nicotine Dependence
|
5.86 score on a scale
Standard Deviation 2.26
|
6.03 score on a scale
Standard Deviation 2.37
|
6.77 score on a scale
Standard Deviation 2.27
|
PRIMARY outcome
Timeframe: End of the treatment (On the fifth day, after completing 20 TMS sessions)Fagerström test for Nicotine Dependence (FTND) is a short, self-report measure that assesses nicotine dependence. It contains six questions, and the total score is calculated as a sum of these six questions. The scores vary from 0 to 10, with lower scores indicating lower dependence on nicotine.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Nicotine Dependence
|
2.31 score on a scale
Standard Deviation 2.62
|
2.03 score on a scale
Standard Deviation 2.08
|
2.57 score on a scale
Standard Deviation 2.69
|
PRIMARY outcome
Timeframe: 1 week follow upFagerström test for Nicotine Dependence (FTND) is a short, self-report measure that assesses nicotine dependence. It contains six questions, and the total score is calculated as a sum of these six questions. The scores vary from 0 to 10, with lower scores indicating lower dependence on nicotine.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=19 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=23 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=25 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Nicotine Dependence
|
1.79 score on a scale
Standard Deviation 1.55
|
2.04 score on a scale
Standard Deviation 2.49
|
2.64 score on a scale
Standard Deviation 2.41
|
PRIMARY outcome
Timeframe: 1 month follow upFagerström test for Nicotine Dependence (FTND) is a short, self-report measure that assesses nicotine dependence. It contains six questions, and the total score is calculated as a sum of these six questions. The scores vary from 0 to 10, with lower scores indicating lower dependence on nicotine.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=17 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=23 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=21 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Nicotine Dependence
|
3.35 score on a scale
Standard Deviation 1.97
|
2.78 score on a scale
Standard Deviation 2.80
|
3.38 score on a scale
Standard Deviation 2.84
|
PRIMARY outcome
Timeframe: 6 months follow upFagerström test for Nicotine Dependence (FTND) is a short, self-report measure that assesses nicotine dependence. It contains six questions, and the total score is calculated as a sum of these six questions. The scores vary from 0 to 10, with lower scores indicating lower dependence on nicotine.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=21 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=28 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=28 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Nicotine Dependence
|
3.71 score on a scale
Standard Deviation 2.43
|
3.32 score on a scale
Standard Deviation 2.74
|
3.96 score on a scale
Standard Deviation 2.57
|
PRIMARY outcome
Timeframe: BaselineThe Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question "How much do you want to smoke right now?", on a scale from 0 "no craving" to 100 "most craving ever experienced" by choosing a response on a visual scale given in front of them on a tablet.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Momentary Craving
|
24.21 score on a scale
Standard Deviation 30.64
|
30.87 score on a scale
Standard Deviation 28.63
|
25.70 score on a scale
Standard Deviation 30.42
|
PRIMARY outcome
Timeframe: Day 1The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question "How much do you want to smoke right now?", on a scale from 0 "no craving" to 100 "most craving ever experienced" by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 1.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Momentary Craving
|
24.55 score on a scale
Standard Deviation 20.66
|
33.13 score on a scale
Standard Deviation 22.12
|
29.03 score on a scale
Standard Deviation 28.59
|
PRIMARY outcome
Timeframe: Day 2The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question "How much do you want to smoke right now?", on a scale from 0 "no craving" to 100 "most craving ever experienced" by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 2.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Momentary Craving
|
15.62 score on a scale
Standard Deviation 16.69
|
23.54 score on a scale
Standard Deviation 18.88
|
21.87 score on a scale
Standard Deviation 24.12
|
PRIMARY outcome
Timeframe: Day 3The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question "How much do you want to smoke right now?", on a scale from 0 "no craving" to 100 "most craving ever experienced" by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 3.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Momentary Craving
|
12.45 score on a scale
Standard Deviation 15.33
|
22.32 score on a scale
Standard Deviation 19.87
|
17.48 score on a scale
Standard Deviation 21.78
|
PRIMARY outcome
Timeframe: Day 4The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question "How much do you want to smoke right now?", on a scale from 0 "no craving" to 100 "most craving ever experienced" by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 4.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Momentary Craving
|
9.16 score on a scale
Standard Deviation 13.12
|
20.14 score on a scale
Standard Deviation 18.41
|
14.44 score on a scale
Standard Deviation 19.18
|
PRIMARY outcome
Timeframe: Day 5The Visual Analogue Scale (VAS) is a psychometric measurement instrument that measures symptom severity on a continuous scale. The VAS can be quickly and repeatedly administered between tasks and it has been used extensively in smoking research with TMS. We used the VAS to assess smoking craving by asking participants to respond to the question "How much do you want to smoke right now?", on a scale from 0 "no craving" to 100 "most craving ever experienced" by choosing a response on a visual scale given in front of them on a tablet. The average of the eight VAS scores, measured prior and post each of the four sessions on Day 5.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Momentary Craving
|
10.57 score on a scale
Standard Deviation 15.74
|
16.08 score on a scale
Standard Deviation 16.14
|
10.46 score on a scale
Standard Deviation 13.13
|
PRIMARY outcome
Timeframe: BaselineTobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
General Craving
|
45.38 Total score
Standard Deviation 17.95
|
52.03 Total score
Standard Deviation 16.20
|
43.83 Total score
Standard Deviation 17.25
|
PRIMARY outcome
Timeframe: End of the treatment (On the fifth day, after completing 20 TMS sessions)Tobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
General Craving
|
30.93 Total score
Standard Deviation 17.05
|
31.97 Total score
Standard Deviation 14.61
|
28.63 Total score
Standard Deviation 13.10
|
PRIMARY outcome
Timeframe: 1 week follow upTobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=19 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=23 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=25 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
General Craving
|
29.84 Total score
Standard Deviation 14.18
|
32.17 Total score
Standard Deviation 21.57
|
27.28 Total score
Standard Deviation 14.82
|
PRIMARY outcome
Timeframe: 1 month follow upTobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=17 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=23 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=21 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
General Craving
|
37.06 Total score
Standard Deviation 17.94
|
30.61 Total score
Standard Deviation 19.63
|
35.24 Total score
Standard Deviation 20.63
|
PRIMARY outcome
Timeframe: 6 months follow upTobacco Craving Questionnaire-Short Form (TCQ-SF) is a self-report measure that assesses tobacco craving in four dimensions. Each factor scale contains three items. TCQ-SF items were rated on a Likert scale of 1 (strongly disagree) to 7 (strongly agree). Total scores vary from 12 to 84, by summing the 12 items and the scores for each factor scale vary from 3 to 21 by summing the three items in each factor scale. A high score indicates high tobacco craving.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=21 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=28 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=28 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
General Craving
|
51.52 Total score
Standard Deviation 19.50
|
38.32 Total score
Standard Deviation 18.22
|
44.68 Total score
Standard Deviation 22.34
|
SECONDARY outcome
Timeframe: BaselinePerceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Perceived Stress
|
5.97 score on a scale
Standard Deviation 2.18
|
6.53 score on a scale
Standard Deviation 2.40
|
5.60 score on a scale
Standard Deviation 1.98
|
SECONDARY outcome
Timeframe: End of the treatment (On the fifth day, after completing 20 TMS sessions)Perceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=29 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Perceived Stress
|
5.21 score on a scale
Standard Deviation 2.47
|
5.90 score on a scale
Standard Deviation 2.34
|
4.60 score on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: 1 week follow upPerceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=19 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=23 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=25 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Perceived Stress
|
4.42 score on a scale
Standard Deviation 2.59
|
6.00 score on a scale
Standard Deviation 2.66
|
4.76 score on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: 1 month follow upPerceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=17 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=23 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=21 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Perceived Stress
|
4.06 score on a scale
Standard Deviation 2.66
|
5.57 score on a scale
Standard Deviation 2.13
|
3.52 score on a scale
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: 6 months follow upPerceived Stress Scale-4 (PSS-4) is a self-report measure that is used to assess psychological stress. PSS-4 items were rated on a Likert scale, ranging from 0 to 4, with those on the positive subscale scored in reverse and the total score was calculated as a sum of these items. The scores vary from 0-16, with a higher score indicating higher perceived stress.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=21 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=28 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=28 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Perceived Stress
|
4.67 score on a scale
Standard Deviation 1.88
|
5.75 score on a scale
Standard Deviation 2.05
|
4.75 score on a scale
Standard Deviation 2.52
|
SECONDARY outcome
Timeframe: BaselineParticipants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=27 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=27 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Motivation to Quit Smoking
|
77.78 score on a scale
Standard Deviation 21.18
|
82.41 score on a scale
Standard Deviation 18.10
|
80.83 score on a scale
Standard Deviation 20.43
|
SECONDARY outcome
Timeframe: End of the treatment (On the fifth day, after completing 20 TMS sessions)Participants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=27 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=27 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Motivation to Quit Smoking
|
82.41 score on a scale
Standard Deviation 20.59
|
84.26 score on a scale
Standard Deviation 19.79
|
80.83 score on a scale
Standard Deviation 23.38
|
SECONDARY outcome
Timeframe: 1 week follow upParticipants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=19 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=23 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=25 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Motivation to Quit Smoking
|
72.37 score on a scale
Standard Deviation 23.41
|
77.17 score on a scale
Standard Deviation 30.07
|
75.00 score on a scale
Standard Deviation 27.95
|
SECONDARY outcome
Timeframe: 1 month follow upParticipants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=17 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=23 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=21 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Motivation to Quit Smoking
|
47.06 score on a scale
Standard Deviation 31.72
|
70.65 score on a scale
Standard Deviation 37.43
|
52.38 score on a scale
Standard Deviation 38.65
|
SECONDARY outcome
Timeframe: 6 months follow upParticipants were asked to estimate how motivated they were to quit smoking from 0% to 100%. Τhe possible answers were: 0%, 25%, 50%, 75% and 100%. Higher values reflect greater motivation to quit smoking.
Outcome measures
| Measure |
Active TMS & Neutral Videos
n=21 Participants
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=28 Participants
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=28 Participants
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
Motivation to Quit Smoking
|
41.67 score on a scale
Standard Deviation 34.76
|
67.86 score on a scale
Standard Deviation 32.53
|
52.68 score on a scale
Standard Deviation 34.92
|
Adverse Events
Active TMS & Neutral Videos
Active TMS & Smoking Videos
Sham TMS & Smoking Videos
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TMS & Neutral Videos
n=29 participants at risk
Received active iTBS stimulation while watching neutral videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Active TMS & Smoking Videos
n=30 participants at risk
Received active iTBS stimulation while watching smoking-related videos
Active intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil.
|
Sham TMS & Smoking Videos
n=30 participants at risk
Received sham stimulation while watching smoking-related videos
Sham intermittent theta burst stimulation: An accelerated iTBS (aiTBS) treatment (4 sessions with 30 minutes break between them) was administered daily for a 5-day period over the left DLPFC using the MagVenture Cool-B65 Active/Placebo (A/P) coil. The MagVenture Cool-B65 Active/Placebo (A/P) coil is designed to support true "double blinded" clinical trials as it can produce active and placebo stimulation by flipping the coil and can mimic tapping sensation during placebo condition During the sham condition, the coil produced the same sound as the real active condition but did not deliver any stimulation on the side of the participant's skull.
|
|---|---|---|---|
|
General disorders
Mild headache
|
6.9%
2/29 • Number of events 2 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
13.3%
4/30 • Number of events 4 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
3.3%
1/30 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Sleepiness
|
10.3%
3/29 • Number of events 3 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
6.7%
2/30 • Number of events 2 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Insomnia
|
3.4%
1/29 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
3.3%
1/30 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Nausea
|
0.00%
0/29 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
3.3%
1/30 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Numbness on stimulation site
|
3.4%
1/29 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Tension
|
3.4%
1/29 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
3.3%
1/30 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Lightheadedness
|
0.00%
0/29 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
3.3%
1/30 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Coghiness
|
3.4%
1/29 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Numbness on stimulation site & Forgetfulness
|
0.00%
0/29 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
3.3%
1/30 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Numbness on stimulation site & Sleepiness
|
3.4%
1/29 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
|
General disorders
Mild headache & Sleepiness
|
3.4%
1/29 • Number of events 1 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
0.00%
0/30 • 1 week
Participants were asked to daily report (during the 5-day treatment period) the adverse events they may have had experienced.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place