Obsessive-Compulsive DisorderNCT04548609

Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD)

A study testing Transcranial Direct Current Stimulation in people with Obsessive-Compulsive Disorder and Pediatric Psychiatric Disorder, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Obsessive-Compulsive Disorder, Pediatric Psychiatric Disorder
What is being tested?: Transcranial Direct Current Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 25 Jan 2021to 5 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Outpatient youth between the ages 10-17 years
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) ≥16 (moderately severe). OCD must be determined to be the primary or co-primary diagnosis using the The Schedule for Affective Disorders and Schizophrenia for School-Age Children- Computer administered version (KSADS-COMP) based on all available information.
Child has a full-scale IQ≥85 as assessed on the Wechsler Abbreviated Scale of Intelligence® Second Edition (WASI®-II) (within 90% CI). To decrease participant burden, the WASI®-II will only be conducted in cases of suspected intellectual disability after meeting with the PI.
English speaking.

Who cannot join

Receiving concurrent psychotherapy for subject's OCD (except maintenance).Subjects receiving pre- established concurrent psychotherapy for at least 8 weeks regarding other psychological issues are eligible for enrollment.
New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritional or therapeutic diets within 6 weeks of study enrolment.
Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics, stimulant, alpha agonist) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications must be stable for 6 weeks prior to baseline. Any medications must remain stable during treatment; consistent with the National Institute of Health (NIH)-funded Child Anxiety Multimodal Study (CAMS) trial, downward adjustments due to side effects may be acceptable and will be discussed with the study child and adolescent psychiatrist and the community psychiatrist.
Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical care.
Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for conduct disorder, autism, bipolar, attention deficit hyperactivity disorder (ADHD), Tourette's syndrome, schizophrenia or schizoaffective disorders
Youth with hoarding symptoms as they may be conceptually and genetically different from other OCD subtypes.

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BMI less than 18.5.
Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, ventriculoperitoneal (VP) shunt, pacemakers.
Active substance dependence (except for tobacco).
Pregnant or nursing females as the effects of tDCS on pregnancy are unknown.
Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Transcranial Direct Current Stimulation (tDCS) Modulation of Neurocognitive Processes Underlying Pediatric Obsessive Compulsive Disorder (OCD)

Read the detailed description

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.

Conditions: Obsessive-Compulsive Disorder, Pediatric Psychiatric Disorder
Being tested: Transcranial Direct Current Stimulation
Keywords: Transcranial Direct Current Stimulation
Medical subject headings: Obsessive-Compulsive Disorder, Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Direct Current StimulationDevice
Also called tDCS
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Study groups in NCT04548609
Study group	Role	What they receive
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. Receives: Device: Transcranial Direct Current Stimulation
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. Receives: Device: Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session

Secondary outcomes (1)

Change in EEG Readings
Degree and type of change in event related potentials (ERPs) amplitudes.
Measured: 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 20215 Mar 2025

First posted14 Sep 2020
Study start25 Jan 2021
Primary completion5 Mar 2025
Study completion5 Mar 2025

Why it stopped: poor recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04548609
Sponsor's protocol ID: 2020P000847
Status last verified: Jun 2026
First submitted: 26 Jun 2020
Last updated: 10 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obsessive-Compulsive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Direct Current Stimulation (tDCS) Modulation of Neurocognitive Processes Underlying Pediatric Obsessive Compulsive Disorder (OCD)
ClinicalTrials.gov ID: NCT04548609
Acronym / sponsor ID: 2020P000847
Conditions: Obsessive-Compulsive Disorder, Pediatric Psychiatric Disorder
Keywords: Transcranial Direct Current Stimulation
Study type: Interventional
Recruitment status: TerminatedReason stopped: poor recruitment
Enrolment: 6 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 25 Jan 2021 (actual)
Primary completion: 5 Mar 2025 (actual)
Study completion: 5 Mar 2025 (actual)
First posted: 14 Sep 2020 (actual)
Results: Posted 10 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Inhibitory Control/ Fear Extinction	Experimental	Device: Transcranial Direct Current StimulationThis 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.
Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior	Experimental	Device: Transcranial Direct Current StimulationThis 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.

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Outpatient youth between the ages 10-17 years
Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) ≥16 (moderately severe). OCD must be determined to be the primary or co-primary diagnosis using the The Schedule for Affective Disorders and Schizophrenia for School-Age Children- Computer administered version (KSADS-COMP) based on all available information.
Child has a full-scale IQ≥85 as assessed on the Wechsler Abbreviated Scale of Intelligence® Second Edition (WASI®-II) (within 90% CI). To decrease participant burden, the WASI®-II will only be conducted in cases of suspected intellectual disability after meeting with the PI.
English speaking.

Key exclusion criteria (11 listed)

Receiving concurrent psychotherapy for subject's OCD (except maintenance).Subjects receiving pre- established concurrent psychotherapy for at least 8 weeks regarding other psychological issues are eligible for enrollment.
New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritional or therapeutic diets within 6 weeks of study enrolment.
Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics, stimulant, alpha agonist) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications must be stable for 6 weeks prior to baseline. Any medications must remain stable during treatment; consistent with the National Institute of Health (NIH)-funded Child Anxiety Multimodal Study (CAMS) trial, downward adjustments due to side effects may be acceptable and will be discussed with the study child and adolescent psychiatrist and the community psychiatrist.
Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical care.
Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for conduct disorder, autism, bipolar, attention deficit hyperactivity disorder (ADHD), Tourette's syndrome, schizophrenia or schizoaffective disorders

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Direct Current StimulationAlso: tDCSIn tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.	Device	Inhibitory Control/ Fear Extinction, Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior

Primary outcome

Change in Stop Signal Task
Time frame: 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session
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).
Change in Fear Extinction Recall Task
Time frame: Within 12-24 hours after the tDCS session the day before
Degree of recall to a previously extinguished conditioned stimulus.
Change in Model-Based Index on the Two-stage Sequential Reinforcement Learning Task (Sequential Spaceship Task)
Time frame: 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session
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.

1 secondary outcome

Change in EEG Readings
Time frame: 90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session

Results and safety

Results posted to the registry on 10 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: ABC	0	0
Arm A: ACB	0	0
Arm A: BAC	0	0
Arm A: BCA	0	0
Arm A: CAB	0	0
Arm A: CBA	0	0
Arm B: ABC	0	0
Arm B: ACB	2	2
Arm B: BAC	0	0
Arm B: BCA	2	1
Arm B: CAB	1	0
Arm B: CBA	1	1

Primary outcome: Change in Stop Signal Task

Time frame: 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session. Mean (Standard Deviation). Unit: milisec

Measure	Arm A: A n = 0	Arm A: B n = 0	Arm A: C n = 0	Arm B: A n = 1	Arm B: B n = 2	Arm B: C n = 2
Value	–	–	–	-30.40	-14.25 (69.79)	-32.74 (27.68)

Population analysed: 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.

Primary outcome: Change in Fear Extinction Recall Task

Time frame: Within 12-24 hours after the tDCS session the day before

Population analysed: 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.

Primary outcome: Change in Model-Based Index on the Two-stage Sequential Reinforcement Learning Task (Sequential Spaceship Task)

Time frame: 40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session. Mean (Standard Deviation). Unit: scores on a scale

Measure	Arm A: A n = 0	Arm A: B n = 0	Arm A: C n = 0	Arm B: A n = 1	Arm B: B n = 1	Arm B: C n = 2
Value	–	–	–	-0.20	0.02	-0.27 (0.07)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4-6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: A	0 of 0	0 of 0	0
Arm A: B	0 of 0	0 of 0	0
Arm A: C	0 of 0	0 of 0	0
Arm B: A	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Arm B: B	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Arm B: C	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joan Camprodon, MD, PhD, MPH principal investigator

Massachusetts General Hospital

Daniel Geller, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Stop Signal Task (time frame: 50 minutes- 20 minutes before and immediately after a single 30 minute tDCS session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04548609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.