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poor recruitment
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In this study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in pediatric patients with obsessive compulsive disorder (OCD).
In this study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in pediatric patients with obsessive compulsive disorder (OCD). The investigators propose two arms of the study that will investigate fear extinction learning and inhibitory control in one arm (A), and goal orientated versus habit-based behavior and inhibitory control in the other (B). All subjects will undergo three study conditions: two with active tDCS to each of two different brain targets and one under sham tDCS. The order of stimulation (sham or active tDCS) will be randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhibitory Control/ Fear Extinction | Experimental | 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. |
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| Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Stop Signal Task | 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). | 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session |
| Change in Fear Extinction Recall Task | Degree of recall to a previously extinguished conditioned stimulus. | Within 12-24 hours after the tDCS session the day before |
| Change in Model-Based Index on the Two-stage Sequential Reinforcement Learning Task (Sequential Spaceship Task) | 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. | 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session |
| Measure | Description | Time Frame |
|---|---|---|
| Change in EEG Readings | Degree and type of change in event related potentials (ERPs) amplitudes. | 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Camprodon, MD, PhD, MPH | Massachusetts General Hospital | Principal Investigator |
| Daniel Geller, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| FG008 | 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. |
| FG009 | 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. |
| FG010 | 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. |
| FG011 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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0 participants were in Arm A: Inhibitory Control / Fear Extinction due to low recruitment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Stop Signal Task | 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). | 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. | Posted | Mean | Standard Deviation | milisec | 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vertigo | Ear and labyrinth disorders | Systematic Assessment | Participant PO-120 experienced vertigo following participation in the first visit and was prescribed meclizine for this. The subject was discontinued for this reason. |
Arm A had zero participants due to low recruitment and study termination. The study involved applying tDCS to children's head. While we were careful to explain that the voltage (9V) and current (2mAmps) applied were extremely low and safe, many parents were anxious about the intervention and it was unexpectedly difficult to enroll subjects. The time to enroll sufficient subjects exceeded our anticipated trial duration and given competing research activities it was decided to terminate the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Geller | Massachusetts General Hospital | 617-726-5527 | dan.geller@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2023 | Mar 26, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Adverse Event |
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| BG001 | Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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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.
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Arm B: A | 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. |
| OG004 | Arm B: B | 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. |
| OG005 | Arm B: C | 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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| Primary | Change in Fear Extinction Recall Task | Degree of recall to a previously extinguished conditioned stimulus. | 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. | Posted | Within 12-24 hours after the tDCS session the day before |
|
|
| Primary | Change in Model-Based Index on the Two-stage Sequential Reinforcement Learning Task (Sequential Spaceship Task) | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session |
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| Secondary | Change in EEG Readings | Degree and type of change in event related potentials (ERPs) amplitudes. | 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. | Posted | Mean | Standard Deviation | microVolts | 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Arm B: A | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Arm B: B | 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. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG005 | Arm B: C | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |