Trial Outcomes & Findings for Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation (NCT NCT05445466)
NCT ID: NCT05445466
Last Updated: 2025-11-06
Results Overview
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
COMPLETED
NA
14 participants
Change from baseline to 5 Day follow-up
2025-11-06
Participant Flow
Individuals were randomized into 1 of 3 protocol arms (tDCS, 10hz tACS or personalized tACS)
Participant milestones
| Measure |
HD-tDCS
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
HD-tACS (Alpha, 10 Hz)
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
Personalized Beta-Gamma HD-tACS
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Beta-Gamma Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
5
|
|
Overall Study
Day 5
|
5
|
4
|
5
|
|
Overall Study
1 Month
|
5
|
4
|
5
|
|
Overall Study
3 Month
|
3
|
2
|
4
|
|
Overall Study
COMPLETED
|
3
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation
Baseline characteristics by cohort
| Measure |
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of passive sham control to the OFC for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: Active-control stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment
|
Personalized Beta-Gamma HD-tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=49 Participants
|
4 Participants
n=50 Participants
|
5 Participants
n=50 Participants
|
14 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Age, Continuous
|
35.2 years
STANDARD_DEVIATION 10.402 • n=49 Participants
|
38.25 years
STANDARD_DEVIATION 12.685 • n=50 Participants
|
30.2 years
STANDARD_DEVIATION 11.476 • n=50 Participants
|
34.29 years
STANDARD_DEVIATION 11.07 • n=50 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=49 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=49 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=49 Participants
|
4 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=49 Participants
|
4 participants
n=50 Participants
|
5 participants
n=50 Participants
|
14 participants
n=50 Participants
|
|
Altman Self-Rating Mania Scale (ASRM)
|
5 score on a scale
n=49 Participants
|
7 score on a scale
n=50 Participants
|
3 score on a scale
n=50 Participants
|
5 score on a scale
n=50 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 5 Day follow-upPopulation: Total score reported.
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Young Mania Rating Scale (YMRS)
Baseline
|
11.8 score on a scale
Interval 9.575 to 13.25
|
5.5 score on a scale
Interval 0.5 to 6.0
|
7.5 score on a scale
Interval 5.5 to 8.0
|
|
Young Mania Rating Scale (YMRS)
Day 5
|
8 score on a scale
Interval 4.75 to 11.125
|
3 score on a scale
Interval 2.0 to 3.5
|
3 score on a scale
Interval 1.5 to 13.0
|
PRIMARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice" R package used for 1 individual 1 Month data. Total score reported.
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Young Mania Rating Scale (YMRS)
Baseline
|
11.8 score on a scale
Interval 9.575 to 13.25
|
5.5 score on a scale
Interval 0.5 to 6.0
|
7.5 score on a scale
Interval 5.5 to 8.0
|
|
Young Mania Rating Scale (YMRS)
1 Month
|
11 score on a scale
Interval 8.0 to 14.25
|
1.5 score on a scale
Interval 1.5 to 4.0
|
4 score on a scale
Interval 1.5 to 5.5
|
PRIMARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Young Mania Rating Scale (YMRS)
Baseline
|
11.8 score on a scale
Interval 9.575 to 13.25
|
5.5 score on a scale
Interval 0.5 to 6.0
|
7.5 score on a scale
Interval 5.5 to 8.0
|
|
Young Mania Rating Scale (YMRS)
3 Month
|
7.5 score on a scale
Interval 5.0 to 9.625
|
2.6 score on a scale
Interval 1.5 to 3.5
|
2 score on a scale
Interval 0.5 to 7.0
|
PRIMARY outcome
Timeframe: Change from baseline to 5 Day follow-upPopulation: Total score reported.
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Altman Self-Rating Mania Scale (ASRM)
Baseline
|
7 score on a scale
Interval 3.75 to 9.5
|
5 score on a scale
Interval 4.0 to 5.0
|
3 score on a scale
Interval 3.0 to 5.0
|
|
Altman Self-Rating Mania Scale (ASRM)
Day 5
|
2 score on a scale
Interval 1.0 to 4.25
|
7 score on a scale
Interval 4.0 to 8.0
|
5 score on a scale
Interval 5.0 to 7.0
|
PRIMARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Altman Self-Rating Mania Scale (ASRM)
Baseline
|
7 score on a scale
Interval 3.75 to 9.5
|
5 score on a scale
Interval 4.0 to 5.0
|
3 score on a scale
Interval 3.0 to 5.0
|
|
Altman Self-Rating Mania Scale (ASRM)
1 Month
|
4 score on a scale
Interval 2.25 to 6.25
|
2 score on a scale
Interval 1.0 to 3.0
|
5 score on a scale
Interval 5.0 to 6.0
|
PRIMARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
The ASRM is a 5-item self rating mania scale, assessing the presence and severity of manic symptoms. The scores for all five items are added together, resulting in a total score that can range from 0 to 20. A score of 6 or higher indicates a high probability of a manic or hypomanic condition.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Altman Self-Rating Mania Scale (ASRM)
Baseline
|
7 score on a scale
Interval 3.75 to 9.5
|
5 score on a scale
Interval 4.0 to 5.0
|
3 score on a scale
Interval 3.0 to 5.0
|
|
Altman Self-Rating Mania Scale (ASRM)
3 Month
|
3.6 score on a scale
Interval 2.25 to 4.5
|
2 score on a scale
Interval 2.0 to 4.0
|
6 score on a scale
Interval 5.0 to 7.2
|
PRIMARY outcome
Timeframe: Cumulative count of hospitalizations for mania from baseline to end of studyPopulation: Cumulative count of hospitalizations for mania from baseline to end of study
Psychiatric hospitalization for mania. Count of hospitalizations from baseline to end of study period assessed at Day 5, 1 Month \& 3 Month.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Psychiatric Hospitalizations for Mania Post Study Entry
Baseline
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
|
Psychiatric Hospitalizations for Mania Post Study Entry
Day 5
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
|
Psychiatric Hospitalizations for Mania Post Study Entry
1 Month
|
1 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
|
Psychiatric Hospitalizations for Mania Post Study Entry
3 Month
|
0 number of hospitalizations
|
0 number of hospitalizations
|
0 number of hospitalizations
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upThe BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Balloon Analogue Risk Task (BART)
Baseline
|
13.5 popped balloons
Interval 11.5 to 15.25
|
16 popped balloons
Interval 10.0 to 17.0
|
13 popped balloons
Interval 11.0 to 19.0
|
|
Balloon Analogue Risk Task (BART)
Day 5
|
13.5 popped balloons
Interval 7.75 to 20.0
|
17 popped balloons
Interval 16.0 to 17.0
|
18 popped balloons
Interval 14.0 to 25.0
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month data
The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Balloon Analogue Risk Task (BART)
1 Month
|
14.1 popped balloons
Interval 10.5 to 18.65
|
15 popped balloons
Interval 15.0 to 16.0
|
27 popped balloons
Interval 17.0 to 28.0
|
|
Balloon Analogue Risk Task (BART)
Baseline
|
13.5 popped balloons
Interval 11.5 to 15.25
|
16 popped balloons
Interval 10.0 to 17.0
|
13 popped balloons
Interval 11.0 to 19.0
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R packaged used to impute 5 individuals' 3 Month data
The BART is a computerized task the measures risk-taking behavior. Participants are tasked with inflating the virtual balloon. The number of pumps a participant chooses to make on each balloon is used as a measure of their risk-taking behavior. More pumps generally indicate a higher tolerance for risk. The balloon bursts at a given point if the participant overfills it. Number of popped balloons reported for a given trial.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Balloon Analogue Risk Task (BART)
Baseline
|
13.5 popped balloons
Interval 11.5 to 15.25
|
16 popped balloons
Interval 10.0 to 17.0
|
13 popped balloons
Interval 11.0 to 19.0
|
|
Balloon Analogue Risk Task (BART)
3 Month
|
14.7 popped balloons
Interval 11.75 to 18.3
|
12.2 popped balloons
Interval 11.0 to 14.0
|
18 popped balloons
Interval 14.0 to 22.0
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upThe Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
The Go/No Go Task
Baseline
|
954.3716154 reaction time (ms) on task
Interval 894.5683204 to 964.7482317
|
876.9768638 reaction time (ms) on task
Interval 675.4974359 to 923.1895604
|
859.6685714 reaction time (ms) on task
Interval 857.6372796 to 1139.709184
|
|
The Go/No Go Task
Day 5
|
878.0193364 reaction time (ms) on task
Interval 871.9321033 to 915.1828861
|
927.1679389 reaction time (ms) on task
Interval 925.6649616 to 1011.031746
|
917.7871795 reaction time (ms) on task
Interval 805.0713097 to 994.2446809
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used for 1 individual's 1 Month data
The Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
The Go/No Go Task
Baseline
|
954.3716154 reaction time (ms) on task
Interval 894.5683204 to 964.7482317
|
876.9768638 reaction time (ms) on task
Interval 675.4974359 to 923.1895604
|
859.6685714 reaction time (ms) on task
Interval 857.6372796 to 1139.709184
|
|
The Go/No Go Task
1 Month
|
919.8986144 reaction time (ms) on task
Interval 910.2266457 to 942.2465073
|
923.5850515 reaction time (ms) on task
Interval 914.8220551 to 939.1815857
|
880.3450882 reaction time (ms) on task
Interval 838.5765306 to 993.5419847
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data
The Go/No Go Task is a computerized task that measures impulsiveness. Participants presented with Go (to respond) and no Go (when not to respond) instructions. Two trials are performed. The first trial consist of two distinct auditory stimuli (both Go stimuli) where the participant is asked to respond with a different number of mouse clicks to the stimuli respectively. The second trial, has a no Go stimuli (where the participant is suppose to withhold a response) and a go stimuli. Reaction time for correct trials only for the entire task are reported in milliseconds.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
The Go/No Go Task
Baseline
|
954.3716154 reaction time (ms) on task
Interval 894.5683204 to 964.7482317
|
876.9768638 reaction time (ms) on task
Interval 675.4974359 to 923.1895604
|
859.6685714 reaction time (ms) on task
Interval 857.6372796 to 1139.709184
|
|
The Go/No Go Task
3 Month
|
925.0182573 reaction time (ms) on task
Interval 897.7525324 to 951.0867497
|
931.8461538 reaction time (ms) on task
Interval 902.5325077 to 953.3693886
|
845.64 reaction time (ms) on task
Interval 803.9641944 to 930.8737113
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upPopulation: Delta/Theta represents the range of 2-7Hz
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Electroencephalography (EEG) Resting State
Baseline Alpha
|
-8.834 peak amplitude measured in microvolts
Interval -9.639 to -6.513
|
-13.336 peak amplitude measured in microvolts
Interval -13.435 to -12.118
|
-11.185 peak amplitude measured in microvolts
Interval -12.112 to -6.792
|
|
Electroencephalography (EEG) Resting State
Baseline Beta
|
-11.636 peak amplitude measured in microvolts
Interval -13.139 to -10.309
|
-17.191 peak amplitude measured in microvolts
Interval -18.932 to -17.076
|
-17.344 peak amplitude measured in microvolts
Interval -18.287 to -16.151
|
|
Electroencephalography (EEG) Resting State
Baseline Gamma
|
-17.087 peak amplitude measured in microvolts
Interval -18.618 to -15.387
|
-21.651 peak amplitude measured in microvolts
Interval -23.656 to -20.064
|
-24.011 peak amplitude measured in microvolts
Interval -24.143 to -20.892
|
|
Electroencephalography (EEG) Resting State
Day 5 Delta/Theta
|
-3.373 peak amplitude measured in microvolts
Interval -4.858 to -1.851
|
-8.844 peak amplitude measured in microvolts
Interval -10.331 to -8.711
|
-3.567 peak amplitude measured in microvolts
Interval -8.164 to -3.369
|
|
Electroencephalography (EEG) Resting State
Day 5 Alpha
|
-8.241 peak amplitude measured in microvolts
Interval -9.049 to -6.13
|
-12.946 peak amplitude measured in microvolts
Interval -14.47 to -11.37
|
-8.445 peak amplitude measured in microvolts
Interval -12.857 to -6.938
|
|
Electroencephalography (EEG) Resting State
Day 5 Beta
|
-12.266 peak amplitude measured in microvolts
Interval -13.787 to -10.604
|
-17.898 peak amplitude measured in microvolts
Interval -17.968 to -16.311
|
-16.360 peak amplitude measured in microvolts
Interval -16.494 to -16.166
|
|
Electroencephalography (EEG) Resting State
Day 5 Gamma
|
-16.232 peak amplitude measured in microvolts
Interval -18.035 to -15.364
|
-20.695 peak amplitude measured in microvolts
Interval -22.511 to -20.69
|
-22.996 peak amplitude measured in microvolts
Interval -24.261 to -22.019
|
|
Electroencephalography (EEG) Resting State
Baseline Delta/Theta
|
-7.555 peak amplitude measured in microvolts
Interval -8.544 to -4.817
|
-9.261 peak amplitude measured in microvolts
Interval -9.654 to -8.72
|
-6.410 peak amplitude measured in microvolts
Interval -9.009 to -5.245
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month Data. Delta/Theta represents the range of 2-7Hz.
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Electroencephalography (EEG) Resting State
Baseline Delta/Theta
|
-7.555 peak amplitude measured in microvolts
Interval -8.544 to -4.817
|
-9.261 peak amplitude measured in microvolts
Interval -9.654 to -8.72
|
-6.410 peak amplitude measured in microvolts
Interval -9.009 to -5.245
|
|
Electroencephalography (EEG) Resting State
Baseline Alpha
|
-8.834 peak amplitude measured in microvolts
Interval -9.639 to -6.513
|
-13.336 peak amplitude measured in microvolts
Interval -13.435 to -12.118
|
-11.185 peak amplitude measured in microvolts
Interval -12.112 to -6.792
|
|
Electroencephalography (EEG) Resting State
Baseline Beta
|
-11.636 peak amplitude measured in microvolts
Interval -13.139 to -10.309
|
-17.191 peak amplitude measured in microvolts
Interval -18.932 to -17.076
|
-17.344 peak amplitude measured in microvolts
Interval -18.287 to -16.151
|
|
Electroencephalography (EEG) Resting State
Baseline Gamma
|
-17.087 peak amplitude measured in microvolts
Interval -18.618 to -15.387
|
-21.651 peak amplitude measured in microvolts
Interval -23.656 to -20.064
|
-24.011 peak amplitude measured in microvolts
Interval -24.143 to -20.892
|
|
Electroencephalography (EEG) Resting State
1 Month Delta/Theta
|
-8.373 peak amplitude measured in microvolts
Interval -9.455 to -7.109
|
-9.775 peak amplitude measured in microvolts
Interval -10.242 to -8.359
|
-4.015 peak amplitude measured in microvolts
Interval -8.554 to -3.696
|
|
Electroencephalography (EEG) Resting State
1 Month Alpha
|
-11.520 peak amplitude measured in microvolts
Interval -12.06 to -10.555
|
-14.921 peak amplitude measured in microvolts
Interval -15.199 to -11.276
|
-10.646 peak amplitude measured in microvolts
Interval -12.675 to -7.025
|
|
Electroencephalography (EEG) Resting State
1 Month Beta
|
-13.489 peak amplitude measured in microvolts
Interval -14.057 to -13.213
|
-16.627 peak amplitude measured in microvolts
Interval -17.518 to -16.425
|
-17.502 peak amplitude measured in microvolts
Interval -18.891 to -16.455
|
|
Electroencephalography (EEG) Resting State
1 Month Gamma
|
-19.739 peak amplitude measured in microvolts
Interval -21.221 to -18.424
|
-19.358 peak amplitude measured in microvolts
Interval -19.363 to -19.102
|
-22.594 peak amplitude measured in microvolts
Interval -24.795 to -21.966
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data. Delta/Theta represents the range of 2-7Hz.
Measuring neural activity at rest consisting of 5 minutes of eyes-open resting-state EEG (rsEEG) was recorded. Fast Fourier transformations were conducted on data, resulting in 4 frequency bands: delta/theta, alpha, beta, and gamma.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Electroencephalography (EEG) Resting State
Baseline Delta/Theta
|
-7.555 peak amplitude measured in microvolts
Interval -8.544 to -4.817
|
-9.261 peak amplitude measured in microvolts
Interval -9.654 to -8.72
|
-6.410 peak amplitude measured in microvolts
Interval -9.009 to -5.245
|
|
Electroencephalography (EEG) Resting State
Baseline Alpha
|
-8.834 peak amplitude measured in microvolts
Interval -9.639 to -6.513
|
-13.336 peak amplitude measured in microvolts
Interval -13.435 to -12.118
|
-11.185 peak amplitude measured in microvolts
Interval -12.112 to -6.792
|
|
Electroencephalography (EEG) Resting State
Baseline Beta
|
-11.636 peak amplitude measured in microvolts
Interval -13.139 to -10.309
|
-17.191 peak amplitude measured in microvolts
Interval -18.932 to -17.076
|
-17.344 peak amplitude measured in microvolts
Interval -18.287 to -16.151
|
|
Electroencephalography (EEG) Resting State
Baseline Gamma
|
-17.087 peak amplitude measured in microvolts
Interval -18.618 to -15.387
|
-21.651 peak amplitude measured in microvolts
Interval -23.656 to -20.064
|
-24.011 peak amplitude measured in microvolts
Interval -24.143 to -20.892
|
|
Electroencephalography (EEG) Resting State
3 Month Delta/Theta
|
-7.362 peak amplitude measured in microvolts
Interval -8.04 to -6.876
|
-8.764 peak amplitude measured in microvolts
Interval -9.704 to -8.22
|
-3.686 peak amplitude measured in microvolts
Interval -8.56 to -3.538
|
|
Electroencephalography (EEG) Resting State
3 Month Alpha
|
-10.615 peak amplitude measured in microvolts
Interval -10.914 to -9.682
|
-14.041 peak amplitude measured in microvolts
Interval -14.599 to -12.839
|
-7.918 peak amplitude measured in microvolts
Interval -11.435 to -7.331
|
|
Electroencephalography (EEG) Resting State
3 Month Beta
|
-13.074 peak amplitude measured in microvolts
Interval -13.41 to -12.645
|
-17.323 peak amplitude measured in microvolts
Interval -18.195 to -17.186
|
-17.643 peak amplitude measured in microvolts
Interval -18.436 to -16.06
|
|
Electroencephalography (EEG) Resting State
3 Month Gamma
|
-19.348 peak amplitude measured in microvolts
Interval -20.173 to -17.743
|
-21.479 peak amplitude measured in microvolts
Interval -21.743 to -20.864
|
-23.863 peak amplitude measured in microvolts
Interval -24.238 to -23.257
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upThe reinforcement learning task is a monetary based learning tasks that included reward and punishment trails. The task presents multiple trials of stimuli where the participant chooses 1 of 2 stimuli presented at a time (one of which is associated with punishment represented by loss of monetary reward while the other is associated with gain of monetary reward). EEG is record during the task and signal is captured during the participants choose and the feedback received. Reported is the peak beta/gamma range response derived from the EEG during reward feedback. This measurement is used from the baseline assessment to inform the personalized beta-gamma range stimulation for the Personalized Beta-Gamma tACS group.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Reinforcement Learning Task
Baseline
|
25.25 peak frequency measured in hertz
Interval 20.0 to 30.875
|
26 peak frequency measured in hertz
Interval 23.5 to 29.0
|
32 peak frequency measured in hertz
Interval 31.0 to 32.0
|
|
Reinforcement Learning Task
Day 5
|
33.75 peak frequency measured in hertz
Interval 30.5 to 35.0
|
28.5 peak frequency measured in hertz
Interval 25.0 to 30.5
|
22 peak frequency measured in hertz
Interval 22.0 to 35.0
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month data
The reinforcement learning task is a monetary based learning tasks that included reward and punishment trails. The task presents multiple trials of stimuli where the participant chooses 1 of 2 stimuli presented at a time (one of which is associated with punishment represented by loss of monetary reward while the other is associated with gain of monetary reward). EEG is record during the task and signal is captured during the participants choose and the feedback received. Reported is the peak beta/gamma range response derived from the EEG during reward feedback. This measurement is used from the baseline assessment to inform the personalized beta-gamma range stimulation for the Personalized Beta-Gamma tACS group.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Reinforcement Learning Task
Baseline
|
25.25 peak frequency measured in hertz
Interval 20.0 to 30.875
|
26 peak frequency measured in hertz
Interval 23.5 to 29.0
|
32 peak frequency measured in hertz
Interval 31.0 to 32.0
|
|
Reinforcement Learning Task
1 Month
|
28.75 peak frequency measured in hertz
Interval 28.5 to 29.875
|
25 peak frequency measured in hertz
Interval 21.5 to 30.5
|
27.5 peak frequency measured in hertz
Interval 22.5 to 28.5
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used for imputing 5 individuals 3 Month data
The reinforcement learning task is a monetary based learning tasks that included reward and punishment trails. The task presents multiple trials of stimuli where the participant chooses 1 of 2 stimuli presented at a time (one of which is associated with punishment represented by loss of monetary reward while the other is associated with gain of monetary reward). EEG is record during the task and signal is captured during the participants choose and the feedback received. Reported is the peak beta/gamma range response derived from the EEG during reward feedback. This measurement is used from the baseline assessment to inform the personalized beta-gamma range stimulation for the Personalized Beta-Gamma tACS group.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Reinforcement Learning Task
Baseline
|
25.25 peak frequency measured in hertz
Interval 20.0 to 30.875
|
26 peak frequency measured in hertz
Interval 23.5 to 29.0
|
32 peak frequency measured in hertz
Interval 31.0 to 32.0
|
|
Reinforcement Learning Task
3 Month
|
29.25 peak frequency measured in hertz
Interval 28.625 to 29.5
|
25.5 peak frequency measured in hertz
Interval 23.7 to 25.6
|
27.5 peak frequency measured in hertz
Interval 27.0 to 30.0
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upPopulation: Total score reported.
The SFS a self-report questionnaire initially designed for people diagnosed with Schizophrenia; consists of 79 items designed to reflect the social skills and performances in different areas of life. Subscores are summed together for a total score. Total score of SFS ranges between 0-223 points. Higher scores mean better social functioning.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Social Functioning Scale (SFS)
Baseline
|
125.5 score on a scale
Interval 120.0 to 129.25
|
161 score on a scale
Interval 133.0 to 166.0
|
142 score on a scale
Interval 129.0 to 152.0
|
|
Social Functioning Scale (SFS)
Day 5
|
125.7 score on a scale
Interval 123.95 to 128.05
|
159 score on a scale
Interval 138.4 to 159.4
|
144 score on a scale
Interval 124.2 to 145.4
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
The SFS a self-report questionnaire initially designed for people diagnosed with Schizophrenia; consists of 79 items designed to reflect the social skills and performances in different areas of life. Subscores are summed together for a total score. Total score of SFS ranges between 0-223 points. Higher scores mean better social functioning.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Social Functioning Scale (SFS)
1 Month
|
130.5 score on a scale
Interval 122.0 to 139.0
|
160 score on a scale
Interval 133.0 to 171.0
|
134 score on a scale
Interval 131.0 to 145.0
|
|
Social Functioning Scale (SFS)
Baseline
|
125.5 score on a scale
Interval 120.0 to 129.25
|
161 score on a scale
Interval 133.0 to 166.0
|
142 score on a scale
Interval 129.0 to 152.0
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
The SFS a self-report questionnaire initially designed for people diagnosed with Schizophrenia; consists of 79 items designed to reflect the social skills and performances in different areas of life. Subscores are summed together for a total score. Total score of SFS ranges between 0-223 points. Higher scores mean better social functioning.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Social Functioning Scale (SFS)
Baseline
|
125.5 score on a scale
Interval 120.0 to 129.25
|
161 score on a scale
Interval 133.0 to 166.0
|
142 score on a scale
Interval 129.0 to 152.0
|
|
Social Functioning Scale (SFS)
3 Month
|
127.2 score on a scale
Interval 116.75 to 135.75
|
156.6 score on a scale
Interval 134.0 to 164.0
|
150 score on a scale
Interval 135.0 to 170.0
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upThe GAF measures how symptoms affect individuals day-to-day life; scored from 0 to 100
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Global Assessment of Functioning (GAF)
Baseline
|
46 score on a scale
Interval 40.75 to 53.25
|
65 score on a scale
Interval 60.0 to 65.0
|
59 score on a scale
Interval 51.0 to 60.0
|
|
Global Assessment of Functioning (GAF)
Day 5
|
50.5 score on a scale
Interval 48.75 to 52.0
|
61 score on a scale
Interval 61.0 to 61.0
|
60 score on a scale
Interval 57.0 to 60.0
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month data
The GAF measures how symptoms affect individuals day-to-day life; scored from 0 to 100
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Global Assessment of Functioning (GAF)
Baseline
|
46 score on a scale
Interval 40.75 to 53.25
|
65 score on a scale
Interval 60.0 to 65.0
|
59 score on a scale
Interval 51.0 to 60.0
|
|
Global Assessment of Functioning (GAF)
1 Month
|
51 score on a scale
Interval 50.75 to 51.25
|
67 score on a scale
Interval 65.0 to 70.0
|
55 score on a scale
Interval 55.0 to 60.0
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data
The GAF measures how symptoms affect individuals day-to-day life; scored from 0 to 100
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Global Assessment of Functioning (GAF)
Baseline
|
46 score on a scale
Interval 40.75 to 53.25
|
65 score on a scale
Interval 60.0 to 65.0
|
59 score on a scale
Interval 51.0 to 60.0
|
|
Global Assessment of Functioning (GAF)
3 Month
|
52.1 score on a scale
Interval 50.55 to 53.65
|
65 score on a scale
Interval 65.0 to 67.0
|
61 score on a scale
Interval 60.0 to 61.0
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upPopulation: Total score reported.
30 items included in the PANSS measuring positive, negative and general symptoms; 7 related to positive symptoms, 7 for negative symptoms, and 16 for general psychopathology Scale. Ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Scores summed for Total Score on scale (30 to 210). Higher scores mean worse clinical symptoms. Total score reported.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
71 score on a scale
Interval 60.75 to 78.5
|
49 score on a scale
Interval 49.0 to 55.0
|
68 score on a scale
Interval 61.0 to 69.0
|
|
Positive and Negative Syndrome Scale (PANSS)
Day 5
|
74.5 score on a scale
Interval 69.0 to 77.0
|
52 score on a scale
Interval 48.0 to 56.0
|
56 score on a scale
Interval 49.0 to 68.0
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individuals 1 Month data. Total score reported.
30 items included in the PANSS measuring positive, negative and general symptoms; 7 related to positive symptoms, 7 for negative symptoms, and 16 for general psychopathology Scale. Ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Scores summed for Total Score on scale (30 to 210). Higher scores mean worse clinical symptoms. Total score reported.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
71 score on a scale
Interval 60.75 to 78.5
|
49 score on a scale
Interval 49.0 to 55.0
|
68 score on a scale
Interval 61.0 to 69.0
|
|
Positive and Negative Syndrome Scale (PANSS)
1 Month
|
75 score on a scale
Interval 73.5 to 78.0
|
50 score on a scale
Interval 42.0 to 54.0
|
55 score on a scale
Interval 52.0 to 55.0
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
30 items included in the PANSS measuring positive, negative and general symptoms; 7 related to positive symptoms, 7 for negative symptoms, and 16 for general psychopathology Scale. Ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. Scores summed for Total Score on scale (30 to 210). Higher scores mean worse clinical symptoms. Total score reported.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Positive and Negative Syndrome Scale (PANSS)
Baseline
|
71 score on a scale
Interval 60.75 to 78.5
|
49 score on a scale
Interval 49.0 to 55.0
|
68 score on a scale
Interval 61.0 to 69.0
|
|
Positive and Negative Syndrome Scale (PANSS)
3 Month
|
73.3 score on a scale
Interval 72.25 to 77.45
|
54.8 score on a scale
Interval 48.6 to 55.0
|
52 score on a scale
Interval 51.0 to 54.6
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upPopulation: Total score reported.
The MADRS is designed to measure depression and severity of symptoms; 0 to 6 indicates no depression, 7 to 19 indicates mild depression, 20 to 34 indicates moderate depression, 35 and greater indicates severe depression. Total score reported (0 to 60).
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Baseline
|
17.5 score on a scale
Interval 11.5 to 23.75
|
8 score on a scale
Interval 8.0 to 11.0
|
10 score on a scale
Interval 8.0 to 29.0
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Day 5
|
14.5 score on a scale
Interval 12.0 to 16.0
|
7 score on a scale
Interval 6.0 to 13.0
|
7 score on a scale
Interval 7.0 to 10.0
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
The MADRS is designed to measure depression and severity of symptoms; 0 to 6 indicates no depression, 7 to 19 indicates mild depression, 20 to 34 indicates moderate depression, 35 and greater indicates severe depression. Total score reported (0 to 60).
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Baseline
|
17.5 score on a scale
Interval 11.5 to 23.75
|
8 score on a scale
Interval 8.0 to 11.0
|
10 score on a scale
Interval 8.0 to 29.0
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
1 Month
|
16 score on a scale
Interval 15.75 to 17.5
|
7 score on a scale
Interval 6.0 to 13.0
|
8 score on a scale
Interval 5.0 to 8.0
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
The MADRS is designed to measure depression and severity of symptoms; 0 to 6 indicates no depression, 7 to 19 indicates mild depression, 20 to 34 indicates moderate depression, 35 and greater indicates severe depression. Total score reported (0 to 60).
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
Baseline
|
17.5 score on a scale
Interval 11.5 to 23.75
|
8 score on a scale
Interval 8.0 to 11.0
|
10 score on a scale
Interval 8.0 to 29.0
|
|
Montgomery-Åsberg Depression Rating Scale (MADRS)
3 Month
|
19.2 score on a scale
Interval 16.25 to 26.0
|
8 score on a scale
Interval 5.0 to 8.0
|
6 score on a scale
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upPopulation: Total score reported.
The BIS-11 is designed to assess the personality/behavioral impulsiveness. The BIS-11 has 30 items and is scored appropriately. Scored to yield a total score, three second-order factors, and six first-order factors. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Higher scores mean more impulsive behavior. Total score reported (30-120).
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Barratt Impulsiveness Scale-11 (BIS-11)
Baseline
|
35 score on a scale
Interval 29.0 to 41.75
|
37 score on a scale
Interval 36.0 to 41.0
|
42 score on a scale
Interval 40.0 to 42.0
|
|
Barratt Impulsiveness Scale-11 (BIS-11)
Day 5
|
38.5 score on a scale
Interval 35.5 to 43.0
|
38 score on a scale
Interval 36.0 to 41.0
|
41 score on a scale
Interval 32.0 to 44.0
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
The BIS-11 is designed to assess the personality/behavioral impulsiveness. The BIS-11 has 30 items and is scored appropriately. Scored to yield a total score, three second-order factors, and six first-order factors. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Higher scores mean more impulsive behavior. Total score reported (30-120).
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Barratt Impulsiveness Scale-11 (BIS-11)
Baseline
|
35 score on a scale
Interval 29.0 to 41.75
|
37 score on a scale
Interval 36.0 to 41.0
|
42 score on a scale
Interval 40.0 to 42.0
|
|
Barratt Impulsiveness Scale-11 (BIS-11)
1 Month
|
38 score on a scale
Interval 27.5 to 47.25
|
35 score on a scale
Interval 34.0 to 40.0
|
40 score on a scale
Interval 36.0 to 42.0
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
The BIS-11 is designed to assess the personality/behavioral impulsiveness. The BIS-11 has 30 items and is scored appropriately. Scored to yield a total score, three second-order factors, and six first-order factors. Each question has a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Higher scores mean more impulsive behavior. Total score reported (30-120).
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Barratt Impulsiveness Scale-11 (BIS-11)
Baseline
|
35 score on a scale
Interval 29.0 to 41.75
|
37 score on a scale
Interval 36.0 to 41.0
|
42 score on a scale
Interval 40.0 to 42.0
|
|
Barratt Impulsiveness Scale-11 (BIS-11)
3 Month
|
38 score on a scale
Interval 37.0 to 38.15
|
35.2 score on a scale
Interval 31.0 to 35.6
|
36 score on a scale
Interval 35.2 to 36.0
|
SECONDARY outcome
Timeframe: Change from baseline to 5 Day follow-upPopulation: Total score reported.
The BACS is designed to assess several domains of cognition; Verbal Memory; Processing Speed; Working Memory; Verbal Fluency; Motor Function; Executive Functioning. Higher scores indicate better cognitive functioning. Total score reported after being transformed into z score based on normative scoring provide by test makers.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Brief Assessment of Cognition (BACS)
Baseline
|
-0.66 score on a test
Interval -1.065 to 0.0025
|
0.44 score on a test
Interval -0.79 to 0.71
|
0.25 score on a test
Interval -0.35 to 0.76
|
|
Brief Assessment of Cognition (BACS)
Day 5
|
-0.74 score on a test
Interval -0.97 to -0.3525
|
0.43 score on a test
Interval -0.26 to 0.71
|
0.3 score on a test
Interval 0.21 to 0.77
|
SECONDARY outcome
Timeframe: Change from baseline to 1-month follow-upPopulation: 'Mice' R package used to impute 1 individual's 1 Month data. Total score reported.
The BACS is designed to assess several domains of cognition; Verbal Memory; Processing Speed; Working Memory; Verbal Fluency; Motor Function; Executive Functioning. Higher scores indicate better cognitive functioning. Total score reported after being transformed into z score based on normative scoring provide by test makers.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Brief Assessment of Cognition (BACS)
Baseline
|
-0.66 score on a test
Interval -1.065 to 0.0025
|
0.44 score on a test
Interval -0.79 to 0.71
|
0.25 score on a test
Interval -0.35 to 0.76
|
|
Brief Assessment of Cognition (BACS)
1 Month
|
-1.26 score on a test
Interval -1.3975 to -0.9485
|
0.01 score on a test
Interval -0.07 to 0.51
|
0.74 score on a test
Interval -0.09 to 0.9
|
SECONDARY outcome
Timeframe: Change from baseline to 3-month follow-upPopulation: 'Mice' R package used to impute 5 individuals 3 Month data. Total score reported.
The BACS is designed to assess several domains of cognition; Verbal Memory; Processing Speed; Working Memory; Verbal Fluency; Motor Function; Executive Functioning. Higher scores indicate better cognitive functioning. Total score reported after being transformed into z score based on normative scoring provide by test makers.
Outcome measures
| Measure |
HD-tACS (Alpha, 10 Hz)
n=4 Participants
10 Hz HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: 10hz HD-tACS stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment.
|
HD-tDCS
n=5 Participants
HD-tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 Participants
Personalized HD-tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Transcranial (Beta-Gamma) Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Brief Assessment of Cognition (BACS)
Baseline
|
-0.66 score on a test
Interval -1.065 to 0.0025
|
0.44 score on a test
Interval -0.79 to 0.71
|
0.25 score on a test
Interval -0.35 to 0.76
|
|
Brief Assessment of Cognition (BACS)
3 Month
|
-0.602 score on a test
Interval -0.7055 to -0.456
|
0.18 score on a test
Interval -0.146 to 0.44
|
0.97 score on a test
Interval 0.384 to 1.58
|
Adverse Events
Active HD-tDCS
Active Control (Alpha, 10 Hz)
Personalized Beta-Gamma tACS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active HD-tDCS
n=5 participants at risk
tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).
High-Definition Transcranial Electrical-Current Stimulation: Non-frequency dependent transcranial electrical stimulation condition for 5 days of twice a day treatment
|
Active Control (Alpha, 10 Hz)
n=4 participants at risk
Passive sham control; Two, twenty-minute sessions of passive sham control to the OFC for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).
High-Definition Transcranial Alternate-Current Stimulation: Active-control stimulation condition will target alpha (10 Hz) for 5 days of twice a day treatment
|
Personalized Beta-Gamma tACS
n=5 participants at risk
tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).
High-Definition Personalized Beta-Gamma Electrical Stimulation: Personalized beta-gamma electrical stimulation for 5 days of twice a day treatment
|
|---|---|---|---|
|
Eye disorders
Eye Fatigue/Pain
|
20.0%
1/5 • Number of events 1 • Adverse events were collected up to 3 months after tES treatment (10 sessions over 1 week) was completed.
|
0.00%
0/4 • Adverse events were collected up to 3 months after tES treatment (10 sessions over 1 week) was completed.
|
0.00%
0/5 • Adverse events were collected up to 3 months after tES treatment (10 sessions over 1 week) was completed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place