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

NCT04548609 | Terminated DMC FDA Device

• 1 other identifier: 2020P000847
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obsessive-Compulsive Disorder; Pediatric Psychiatric Disorder

Keywords

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (3)

• Change in Stop Signal Task

  Ability to Inhibit a Response Task

  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 Sequential Spaceship Task

  Ability to increase the proportion of Goal-Orientated versus Habit-Based Behaviour

  40 minutes- immediately before and 10 minutes after a 30 minute single tDCS session

Secondary Outcomes (1)

• Change in EEG readings

  90 minutes- 30 minutes before and 30 minutes after a single 30 minute tDCS session

Study Arms (2)

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.

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.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.

Also known as: tDCS

Inhibitory Control/ Fear Extinction; Inhibitory Control/ Goal-Orientated vs Habit-Based Behavior

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Neurodevelopmental Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Joan Camprodon, MD, PhD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Daniel Geller, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Division of Neuropsychiatry, Director of TMS Clinic, Director of Lab for Neuropsychiatry and Neuromodulation

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: September 14, 2020
• Study Start: January 25, 2021
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (1)