Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD)
NCT ID: NCT04548609
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2021-01-25
2025-03-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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.
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
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.
Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Interventions
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Transcranial Direct Current Stimulation
In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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.
4. English speaking.
Exclusion Criteria
2. 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.
3. 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.
4. Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical care.
5. 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
6. Youth with hoarding symptoms as they may be conceptually and genetically different from other OCD subtypes.
7. BMI less than 18.5.
8. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, ventriculoperitoneal (VP) shunt, pacemakers.
9. Active substance dependence (except for tobacco).
10. Pregnant or nursing females as the effects of tDCS on pregnancy are unknown.
11. Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study.
10 Years
17 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Joan A Camprodon, MD MPH PhD
Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation
Principal Investigators
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Joan Camprodon, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Daniel Geller, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2020P000847
Identifier Type: -
Identifier Source: org_study_id