Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD) (NCT NCT04548609)
NCT ID: NCT04548609
Last Updated: 2026-07-10
Results Overview
Ability to Inhibit a Response Task For the stop-signal task, the outcome of inhibitory control is measured by the stop signal reaction time (SSRT), calculated by subtracting the stop signal delay (SSD) from the go signal response time (RT).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session
Results posted on
2026-07-10
Participant Flow
Participant milestones
| Measure |
Arm A: ABC
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence ABC, where A is active tDCS to the right vlPFC first, then B is active tDCS to the pre-SMA, and then C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: ACB
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence ACB, where A is active tDCS to the right vlPFC first, then C is sham tDCS, and then B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: BAC
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence BAC, where B is active tDCS to the pre-SMA first, then A is active tDCS to the right vlPFC, and then C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: BCA
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence BCA, where B is active tDCS to the pre-SMA first, then C is sham tDCS, and then A is active tDCS to the right vlPFC.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: CAB
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence CAB, where C is sham tDCS first, then A is active tDCS to the right vlPFC, and then B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: CBA
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence CBA, where C is sham tDCS first, then B is active tDCS to the pre-SMA, and then A is active tDCS to the right vlPFC.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: ABC
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence ABC, where A is active tDCS to the right vlPFC first, then B is active tDCS to the pre-SMA, and then C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: ACB
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence ACB, where A is active tDCS to the right vlPFC first, then C is sham tDCS, and then B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: BAC
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence BAC, where B is active tDCS to the pre-SMA first, then A is active tDCS to the right vlPFC, and then C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: BCA
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence BCA, where B is active tDCS to the pre-SMA first, then C is sham tDCS, and then A is active tDCS to the right vlPFC.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: CAB
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence CAB, where C is sham tDCS first, then A is active tDCS to the right vlPFC, and then B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: CBA
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence CBA, where C is sham tDCS first, then B is active tDCS to the pre-SMA, and then A is active tDCS to the right vlPFC.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
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Overall Study
STARTED
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0
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0
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0
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0
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0
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2
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0
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2
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1
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1
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Overall Study
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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2
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0
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1
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0
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1
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Overall Study
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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1
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0
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Reasons for withdrawal
| Measure |
Arm A: ABC
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence ABC, where A is active tDCS to the right vlPFC first, then B is active tDCS to the pre-SMA, and then C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: ACB
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence ACB, where A is active tDCS to the right vlPFC first, then C is sham tDCS, and then B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: BAC
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence BAC, where B is active tDCS to the pre-SMA first, then A is active tDCS to the right vlPFC, and then C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: BCA
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence BCA, where B is active tDCS to the pre-SMA first, then C is sham tDCS, and then A is active tDCS to the right vlPFC.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: CAB
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence CAB, where C is sham tDCS first, then A is active tDCS to the right vlPFC, and then B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: CBA
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence CBA, where C is sham tDCS first, then B is active tDCS to the pre-SMA, and then A is active tDCS to the right vlPFC.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: ABC
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence ABC, where A is active tDCS to the right vlPFC first, then B is active tDCS to the pre-SMA, and then C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: ACB
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence ACB, where A is active tDCS to the right vlPFC first, then C is sham tDCS, and then B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: BAC
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence BAC, where B is active tDCS to the pre-SMA first, then A is active tDCS to the right vlPFC, and then C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: BCA
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence BCA, where B is active tDCS to the pre-SMA first, then C is sham tDCS, and then A is active tDCS to the right vlPFC.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: CAB
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence CAB, where C is sham tDCS first, then A is active tDCS to the right vlPFC, and then B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: CBA
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This particular group will undergo three sessions of tDCS with the order of the sessions randomized to the treatment sequence CBA, where C is sham tDCS first, then B is active tDCS to the pre-SMA, and then A is active tDCS to the right vlPFC.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
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Overall Study
Withdrawal by Subject
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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Overall Study
Adverse Event
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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Baseline Characteristics
Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD)
Baseline characteristics by cohort
| Measure |
Inhibitory Control/ Fear Extinction
This arm will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Participants will be randomized to only one of six possible treatment sequences: ABC, BCA, CAB, ACB, BAC, or CBA, where A is active tDCS target 1, B is active tDCS target 2, and C is sham tDCS. Thus, each participant who completes the study will receive all three stimulation interventions, with the order determined by the assigned treatment sequence. However, participants will not cross over between treatment sequences.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior
n=6 Participants
This arm will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. This group will undergo three sessions of tDCS: two active sessions and one sham session. The order of the sessions is randomized.
Participants will be randomized to only one of six possible treatment sequences: ABC, BCA, CAB, ACB, BAC, or CBA, where A is active tDCS target 1, B is active tDCS target 2, and C is sham tDCS. Thus, each participant who completes the study will receive all three stimulation interventions, with the order determined by the assigned treatment sequence. However, participants will not cross over between treatment sequences.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Total
n=6 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
—
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14.83 years
STANDARD_DEVIATION 1.47 • n=27 Participants
|
14.83 years
STANDARD_DEVIATION 1.47 • n=267 Participants
|
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Sex: Female, Male
Female
|
—
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2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
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Sex: Female, Male
Male
|
—
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4 Participants
n=27 Participants
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4 Participants
n=267 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
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5 Participants
n=27 Participants
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5 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
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1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
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0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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—
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0 Participants
n=27 Participants
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0 Participants
n=267 Participants
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|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=27 Participants
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0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
—
|
5 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS sessionPopulation: Participants were randomized to only one of six possible treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA) and they did not cross over between treatment sequences. Therefore, each participant who completed the study received all three stimulation interventions, with the order determined by the assigned treatment sequence. For this task, data were collected for each separate stimulation episode, and analyses included all participants who had both pre- and post-stimulation data.
Ability to Inhibit a Response Task For the stop-signal task, the outcome of inhibitory control is measured by the stop signal reaction time (SSRT), calculated by subtracting the stop signal delay (SSD) from the go signal response time (RT).
Outcome measures
| Measure |
Arm A: A
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where A is active tDCS to the right vlPFC first.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: B
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: C
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: A
n=1 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where A is active tDCS to the right vlPFC first.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: B
n=2 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: C
n=2 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
|---|---|---|---|---|---|---|
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Change in Stop Signal Task
|
—
|
—
|
—
|
-30.40 milisec
|
-14.25 milisec
Standard Deviation 69.79
|
-32.74 milisec
Standard Deviation 27.68
|
PRIMARY outcome
Timeframe: Within 12-24 hours after the tDCS session the day beforePopulation: Data for this measure were not collected because no participants were enrolled in Arm A due to low recruitment, and the Fear Extinction Recall Task was for Arm A participants only, as per protocol.
Degree of recall to a previously extinguished conditioned stimulus.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS sessionPopulation: Participants were randomized to only one of six possible treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA) and they did not cross over between treatment sequences. Therefore, each participant who completed the study received all three stimulation interventions, with the order determined by the assigned treatment sequence. For this task, data were collected for each separate stimulation episode, and analyses included all participants who had both pre- and post-stimulation data.
Decision-making task that quantifies the relative contribution of model-based (goal-directed) vs model-free (habit-based) choice strategies. The Model-Based Index, is derived from each participant's probability of repeating their first-stage choice on the following trial, computed separately for four combinations of prior-trial outcome (rewarded or unrewarded) and transition type (common or rare): (stay probability after rewarded-common trials minus stay probability after rewarded-rare trials) plus (stay probability after unrewarded-rare trials minus stay probability after unrewarded-common trials). The index ranges from -2.0 to 2.0. A score near 0 indicates choices driven primarily by recent reward history regardless of transition type (model-free/habit-based responding), while higher positive scores indicate choices that are additionally sensitive to the task's transition structure (model-based/goal-directed responding). Higher scores means greater degree of goal-directed control.
Outcome measures
| Measure |
Arm A: A
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where A is active tDCS to the right vlPFC first.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: B
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: C
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: A
n=1 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where A is active tDCS to the right vlPFC first.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: B
n=1 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: C
n=2 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
|---|---|---|---|---|---|---|
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Change in Model-Based Index on the Two-stage Sequential Reinforcement Learning Task (Sequential Spaceship Task)
|
—
|
—
|
—
|
-0.20 scores on a scale
|
0.02 scores on a scale
|
-0.27 scores on a scale
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS sessionPopulation: Participants were randomized to only one of six possible treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA) and they did not cross over between treatment sequences. Therefore, each participant who completed the study received all three stimulation interventions, with the order determined by the assigned treatment sequence. For this measure, data were collected for each separate stimulation episode, and analyses included all participants who had both pre- and post-stimulation data.
Degree and type of change in event related potentials (ERPs) amplitudes.
Outcome measures
| Measure |
Arm A: A
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where A is active tDCS to the right vlPFC first.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: B
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: C
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: A
n=1 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where A is active tDCS to the right vlPFC first.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: B
n=1 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: C
n=1 Participants
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
|---|---|---|---|---|---|---|
|
Change in EEG Readings
|
—
|
—
|
—
|
4.96 microVolts
|
0.84 microVolts
|
9.78 microVolts
|
Adverse Events
Arm A: A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm A: B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm A: C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B: C
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 |
Arm A: A
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where A is active tDCS to the right vlPFC first.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: B
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm A: C
Arm A (Inhibitory Control/ Fear Extinction) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Fear Extinction. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: A
n=4 participants at risk
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where A is active tDCS to the right vlPFC first.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: B
n=5 participants at risk
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where B is active tDCS to the pre-SMA.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
Arm B: C
n=4 participants at risk
Arm B (Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior) will investigate the effect of tDCS on tasks assessing Inhibitory Control/ Goal-Orientated versus Habit-Based Behavior. Each participant will undergo three sessions of tDCS, with the order of the sessions randomized to the treatment sequence, where C is sham tDCS.
Transcranial Direct Current Stimulation: In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
vertigo
|
—
0/0 • 4-6 weeks
Arm A enrolled 0 participants due to low recruitment. Arm B participants were randomized to one of six sequences (ABC, BCA, CAB, ACB, BAC, or CBA; A=active tDCS to the right vlPFC, B=active tDCS to the pre-SMA, C=sham tDCS) without crossover between sequences; study completers received all three stimulation interventions. 4 participants completed, 1 dropped out after Visit 1, and 1 dropped out during Visit 1 (pre-stim). AEs were monitored and collected separately for each intervention.
|
—
0/0 • 4-6 weeks
Arm A enrolled 0 participants due to low recruitment. Arm B participants were randomized to one of six sequences (ABC, BCA, CAB, ACB, BAC, or CBA; A=active tDCS to the right vlPFC, B=active tDCS to the pre-SMA, C=sham tDCS) without crossover between sequences; study completers received all three stimulation interventions. 4 participants completed, 1 dropped out after Visit 1, and 1 dropped out during Visit 1 (pre-stim). AEs were monitored and collected separately for each intervention.
|
—
0/0 • 4-6 weeks
Arm A enrolled 0 participants due to low recruitment. Arm B participants were randomized to one of six sequences (ABC, BCA, CAB, ACB, BAC, or CBA; A=active tDCS to the right vlPFC, B=active tDCS to the pre-SMA, C=sham tDCS) without crossover between sequences; study completers received all three stimulation interventions. 4 participants completed, 1 dropped out after Visit 1, and 1 dropped out during Visit 1 (pre-stim). AEs were monitored and collected separately for each intervention.
|
0.00%
0/4 • 4-6 weeks
Arm A enrolled 0 participants due to low recruitment. Arm B participants were randomized to one of six sequences (ABC, BCA, CAB, ACB, BAC, or CBA; A=active tDCS to the right vlPFC, B=active tDCS to the pre-SMA, C=sham tDCS) without crossover between sequences; study completers received all three stimulation interventions. 4 participants completed, 1 dropped out after Visit 1, and 1 dropped out during Visit 1 (pre-stim). AEs were monitored and collected separately for each intervention.
|
20.0%
1/5 • 4-6 weeks
Arm A enrolled 0 participants due to low recruitment. Arm B participants were randomized to one of six sequences (ABC, BCA, CAB, ACB, BAC, or CBA; A=active tDCS to the right vlPFC, B=active tDCS to the pre-SMA, C=sham tDCS) without crossover between sequences; study completers received all three stimulation interventions. 4 participants completed, 1 dropped out after Visit 1, and 1 dropped out during Visit 1 (pre-stim). AEs were monitored and collected separately for each intervention.
|
0.00%
0/4 • 4-6 weeks
Arm A enrolled 0 participants due to low recruitment. Arm B participants were randomized to one of six sequences (ABC, BCA, CAB, ACB, BAC, or CBA; A=active tDCS to the right vlPFC, B=active tDCS to the pre-SMA, C=sham tDCS) without crossover between sequences; study completers received all three stimulation interventions. 4 participants completed, 1 dropped out after Visit 1, and 1 dropped out during Visit 1 (pre-stim). AEs were monitored and collected separately for each intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place