Trial Outcomes & Findings for tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia (NCT NCT03588728)
NCT ID: NCT03588728
Last Updated: 2023-03-13
Results Overview
the MATRICS Consensus battery (MCCB) is a cognitive battery of tests for assessing cognition-enhancing treatments for schizophrenia through a broadly based scientific evaluation of measures. Change in cognitive measures of MATRICS Consensus Cognitive Battery (MCCB). Post-intervention minus baseline. Scale is scored 0-100. Difference score range is (-100 to 100) with positive scores reflecting improvement.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Baseline to approximately 4 weeks
Results posted on
2023-03-13
Participant Flow
Participant milestones
| Measure |
CR + tDCS
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
12
|
11
|
|
Overall Study
COMPLETED
|
7
|
6
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
CR + tDCS
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Overall Study
Did not meet eligibility ctriteria
|
0
|
0
|
3
|
2
|
|
Overall Study
Lab shut down due to COVID-19
|
0
|
0
|
0
|
1
|
|
Overall Study
multiple technical issues
|
1
|
0
|
0
|
0
|
|
Overall Study
Hospitalized for COVID
|
1
|
0
|
0
|
0
|
|
Overall Study
Schedule change unable to attend sessions
|
1
|
0
|
0
|
0
|
Baseline Characteristics
tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia
Baseline characteristics by cohort
| Measure |
CR + tDCS
n=7 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=6 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=9 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=8 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
52.5 years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
50.9 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
48.4 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 10.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
|
Nicotine Dependence Score
|
4.7 units on a scale
STANDARD_DEVIATION 1.7 • n=99 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.6 • n=107 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 1.1 • n=206 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.6 • n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to approximately 4 weeksthe MATRICS Consensus battery (MCCB) is a cognitive battery of tests for assessing cognition-enhancing treatments for schizophrenia through a broadly based scientific evaluation of measures. Change in cognitive measures of MATRICS Consensus Cognitive Battery (MCCB). Post-intervention minus baseline. Scale is scored 0-100. Difference score range is (-100 to 100) with positive scores reflecting improvement.
Outcome measures
| Measure |
CR + tDCS
n=7 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=6 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=9 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=8 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS™): MATRICS Consensus Cognitive Battery (MCCB)
|
3.6 score on a scale
Standard Deviation 4.0
|
2.3 score on a scale
Standard Deviation 8.6
|
3.1 score on a scale
Standard Deviation 3.6
|
1.8 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksPopulation: Three subjects were removed from analyses due to misunderstanding the computerized rating system.
Change in cue-induced craving indexed as change in self-report craving on the questionnaire of smoking urges, 4-item version (QSU-4) from baseline to end of intervention. Craving rating range = 0-100. Difference scores range from (-100 to 100) with a negative score reflecting improvement.
Outcome measures
| Measure |
CR + tDCS
n=6 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=5 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=9 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=7 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Cue-Reactivity
|
-6.4 score on a scale
Standard Deviation 38.1
|
-6.2 score on a scale
Standard Deviation 14.3
|
-3.0 score on a scale
Standard Deviation 24.5
|
2.6 score on a scale
Standard Deviation 29.5
|
SECONDARY outcome
Timeframe: Baseline and at approximately 4 weeksPopulation: Participants who did not smoke at baseline during cue reactivity were excluded from the analyses. This included 1 from arm CR + tDCS, 2 from CR + sham tDCS, and 2 from control CR + tDCS.
Change in mean cigarette puff volume
Outcome measures
| Measure |
CR + tDCS
n=6 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=4 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=7 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=8 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Cigarette Puff Volume
|
-218.8 Milliliters
Standard Deviation 450.9
|
-90.7 Milliliters
Standard Deviation 345.0
|
-9.9 Milliliters
Standard Deviation 268.0
|
27.4 Milliliters
Standard Deviation 623.5
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksPopulation: Participants who did not smoke at baseline during cue reactivity were excluded from this analysis. This included 1 from arm CR + tDCS, 2 from CR + sham tDCS, and 2 from control CR + tDCS.
Change in mean latency to first cigarette puff
Outcome measures
| Measure |
CR + tDCS
n=6 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=4 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=7 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=8 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Latency to First Cigarette Puff
|
119.0 seconds
Standard Deviation 197.1
|
182.8 seconds
Standard Deviation 243.7
|
19.1 seconds
Standard Deviation 65.1
|
96.5 seconds
Standard Deviation 188.3
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksAX version of the CPT measures a participant's active maintenance and cognitive control. In this task, the participant is presented with a series of trials in which they are instructed to make a response which distinguishes between stimuli. Here the stimuli included are: smoking, nonsmoking, person, non-person). Assessment is of Post - Pre intervention difference in reaction time to respond to stimuli on the AX Version of the Continuous Performance Task (AX-CPT)
Outcome measures
| Measure |
CR + tDCS
n=7 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=6 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=9 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=8 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
AX Version of the Continuous Performance Task (AX-CPT) Reaction Time
|
-59.5 milliseconds
Standard Deviation 62.9
|
-37.8 milliseconds
Standard Deviation 47.4
|
4.3 milliseconds
Standard Deviation 29.8
|
-7.2 milliseconds
Standard Deviation 30.8
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksPost minus pre-intervention difference Reaction time variability for hits on the AX Version of the Continuous Performance Task (AX-CPT). A negative value indicates improvement.
Outcome measures
| Measure |
CR + tDCS
n=7 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=6 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=9 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=8 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
AX Version of the Continuous Performance Task (AX-CPT) Reaction Time Variability
|
-49463.5 milliseconds
Standard Deviation 71684.1
|
12828.3 milliseconds
Standard Deviation 63752.7
|
22570.7 milliseconds
Standard Deviation 83194.9
|
8292.96 milliseconds
Standard Deviation 74462.3
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksPopulation: Subjects were removed from analysis if their data was too noisy from excessive coughing or moving around.
Difference in change scores (post minus pre-intervention) in N170 Amplitude between smoking and neutral images. A more negative score indicates greater improvement.
Outcome measures
| Measure |
CR + tDCS
n=7 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=5 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=6 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=5 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
EEG (Electroencephalogram) N170 Amplitude
|
-1.9 microvolts
Standard Deviation 1.8
|
0.2 microvolts
Standard Deviation 1.9
|
-0.8 microvolts
Standard Deviation 2.2
|
0.6 microvolts
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksPopulation: Subjects were removed from analysis if their data was too noisy from excessive coughing or moving around.
Difference in CNV between the A and X in the AX-CPT Task. More negative indicates larger CNV.
Outcome measures
| Measure |
CR + tDCS
n=7 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=5 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=7 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=5 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
EEG (Electroencephalogram) Contingent Negative Variation (CNV)
|
0.8 microvolts
Standard Deviation 1.7
|
0.6 microvolts
Standard Deviation 1.5
|
0.8 microvolts
Standard Deviation 1.3
|
1.2 microvolts
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksPopulation: Subjects were removed from analysis if their data was too noisy from excessive coughing or moving around.
Difference in ERD between the A and X in AX-CPT during EEG assessment of Beta-Band Event-Related Desynchronization (ERD). More negative values indicate greater Beta-band ERD at post-intervention.
Outcome measures
| Measure |
CR + tDCS
n=7 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=5 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=7 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=5 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
EEG (Electroencephalogram) Beta-Band Event-Related Desynchronization (ERD)
|
-3.8 microvolts squared
Standard Deviation 2.6
|
-2.6 microvolts squared
Standard Deviation 3.1
|
-3.6 microvolts squared
Standard Deviation 6.2
|
-0.2 microvolts squared
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksPopulation: The baseline data for one subject in CR + tDCS did not save.
Post minus Pre-intervention difference in Reaction time between smoking and neutral images presented with the ASCET task. A negative RT indicates improvement.
Outcome measures
| Measure |
CR + tDCS
n=6 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=6 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=9 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=8 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Attention & Smoking Cue Exposure Task (ASCET)
|
-21.9 milliseconds
Standard Deviation 19.6
|
-21.7 milliseconds
Standard Deviation 23.0
|
-10.5 milliseconds
Standard Deviation 23.3
|
-8.6 milliseconds
Standard Deviation 32.8
|
SECONDARY outcome
Timeframe: Baseline to approximately 4 weeksPopulation: Participants who did not smoke at baseline during cue reactivity were excluded from this analysis. This included 1 from arm CR + tDCS, 2 from CR + sham tDCS, and 2 from control CR + tDCS.
Change in number of puffs on cigarettes assessment during smoking topography measurement during the cue reactivity task. Number of puffs was assessed during pre-training cue reactivity and again during post-training cue reactivity.
Outcome measures
| Measure |
CR + tDCS
n=6 Participants
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=4 Participants
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=7 Participants
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=8 Participants
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Total Number of Puffs
|
-7.3 puffs
Standard Deviation 11.3
|
0.8 puffs
Standard Deviation 7.8
|
-2.0 puffs
Standard Deviation 11.1
|
2.0 puffs
Standard Deviation 15.7
|
Adverse Events
CR + tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CR + Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control CR + tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control CR + Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CR + tDCS
n=10 participants at risk
Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
CR + Sham tDCS
n=6 participants at risk
Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive Remediation (CR): Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
|
Control CR + tDCS
n=12 participants at risk
Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial direct current stimulation targeting the right inferior frontal gyrus
|
Control CR + Sham tDCS
n=11 participants at risk
Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)
|
|---|---|---|---|---|
|
Infections and infestations
Illness not related to study participation
|
10.0%
1/10 • Number of events 1 • Participants were assessed for adverse events from the time they completed informed content to the end of their participation in the study, which was approximately 4 weeks.
|
0.00%
0/6 • Participants were assessed for adverse events from the time they completed informed content to the end of their participation in the study, which was approximately 4 weeks.
|
0.00%
0/12 • Participants were assessed for adverse events from the time they completed informed content to the end of their participation in the study, which was approximately 4 weeks.
|
0.00%
0/11 • Participants were assessed for adverse events from the time they completed informed content to the end of their participation in the study, which was approximately 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place