Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation (rTMS) for Nicotine Addiction (NCT NCT02401672)
NCT ID: NCT02401672
Last Updated: 2020-09-21
Results Overview
Nicotine consumption: We use cigarette diary for participant to record number of cigarettes smoked per day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
2 weeks of treatment
Results posted on
2020-09-21
Participant Flow
Assessed for eligibility (n=327), Excluded 280, Not meeting inclusion criteria: 275, and declined to participate: 5, lost contact before screening visit: 5
Participant milestones
| Measure |
Active TMS
Repetitive TMS pulse stimulation
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
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Sham TMS
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
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|---|---|---|
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Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Active TMS
Repetitive TMS pulse stimulation
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
|
Sham TMS
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
1
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3
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Baseline Characteristics
Repetitive Transcranial Magnetic Stimulation (rTMS) for Nicotine Addiction
Baseline characteristics by cohort
| Measure |
Active TMS
n=22 Participants
Repetitive TMS pulse stimulation
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
|
Sham TMS
n=20 Participants
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
|
Total
n=42 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
40.64 years
STANDARD_DEVIATION 10.36 • n=99 Participants
|
43.75 years
STANDARD_DEVIATION 10.36 • n=107 Participants
|
42.12 years
STANDARD_DEVIATION 10.78 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · African Americans
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
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22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
cigarettes per day
|
18.2 cigarettes per day
STANDARD_DEVIATION 4.8 • n=99 Participants
|
20.9 cigarettes per day
STANDARD_DEVIATION 10.2 • n=107 Participants
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19.5 cigarettes per day
STANDARD_DEVIATION 7.8 • n=206 Participants
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PRIMARY outcome
Timeframe: 2 weeks of treatmentPopulation: two groups t test for percentage changed cigarettes per day: mixed model.
Nicotine consumption: We use cigarette diary for participant to record number of cigarettes smoked per day.
Outcome measures
| Measure |
Active TMS
n=21 Participants
Repetitive TMS pulse stimulation
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
|
Sham TMS
n=17 Participants
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
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|---|---|---|
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Nicotine Consumption: Number of Cigarettes Per Day
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11.60 the number of cigarette
Standard Deviation 6.93
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13.73 the number of cigarette
Standard Deviation 9.18
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PRIMARY outcome
Timeframe: 2 weeksPopulation: We compared active group to sham group in the percentage of reduction in cigarettes smoked per day.
percentage of change of cigarettes per day =100\* ( cigarettes smoked per day at baseline - cigarettes smoked per day at the end of treatment) / cigarettes smoked per day at baseline
Outcome measures
| Measure |
Active TMS
n=21 Participants
Repetitive TMS pulse stimulation
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
|
Sham TMS
n=17 Participants
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
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|---|---|---|
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Percentage of Change of Cigarettes Per Day
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62.93 % change
Standard Deviation 10.74
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38.43 % change
Standard Deviation 10.63
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SECONDARY outcome
Timeframe: 2 weeks of treatmentPopulation: Weekly ratings for mixed model repeated measures. We reported the group means which includes 5 points each group.
The Brief Questionnaire of Smoking Urges (QSU-Brief) consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire. A higher number represents a stronger smoking urges. A lower score represents a weaker smoking urges. The lowest score is 10. The highest score is 70.
Outcome measures
| Measure |
Active TMS
n=21 Participants
Repetitive TMS pulse stimulation
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
|
Sham TMS
n=17 Participants
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
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|---|---|---|
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Average Nicotine Craving as Assessed by the Questionnaire of Smoking Urges-Brief
|
25.01 score on a scale
Standard Deviation 14.45
|
29.93 score on a scale
Standard Deviation 13.12
|
SECONDARY outcome
Timeframe: 2 weeks of treatmentPopulation: Quitting at target quit date.
Quitting smoking on the target quit date.
Outcome measures
| Measure |
Active TMS
n=21 Participants
Repetitive TMS pulse stimulation
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
|
Sham TMS
n=17 Participants
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
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|---|---|---|
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The Number of Participants Quitting on the Target Quit Date
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5 participants
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0 participants
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Adverse Events
Active TMS
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Sham TMS
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active TMS
n=21 participants at risk
Repetitive TMS pulse stimulation
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
|
Sham TMS
n=17 participants at risk
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Transcranial magnetic stimulation: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
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|---|---|---|
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Nervous system disorders
headache
|
66.7%
14/21 • Number of events 14 • Two weeks
When the active TMS treatment started, the participant could not be tolerable for the stimulation. The participant dropped out the study. We asked for any side effects during the treatment course. E.g. Headache, discomfort, unpleasant or scalp pain.
|
47.1%
8/17 • Number of events 8 • Two weeks
When the active TMS treatment started, the participant could not be tolerable for the stimulation. The participant dropped out the study. We asked for any side effects during the treatment course. E.g. Headache, discomfort, unpleasant or scalp pain.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place