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

Last updated: April 1, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obsessive-compulsive Disorder

Panic Disorders

Anxiety Disorders

Treatment

Transcranial Direct Current Stimulation

Clinical Study ID

NCT04548609
2020P000847
  • Ages 10-17
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Outpatient youth between the ages 10-17 years
  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 TheSchedule for Affective Disorders and Schizophrenia for School-Age Children- Computeradministered version (KSADS-COMP) based on all available information.
  3. Child has a full-scale IQ≥85 as assessed on the Wechsler Abbreviated Scale ofIntelligence® Second Edition (WASI®-II) (within 90% CI). To decrease participantburden, the WASI®-II will only be conducted in cases of suspected intellectualdisability after meeting with the PI.
  4. English speaking.

Exclusion

Exclusion Criteria:

  1. Receiving concurrent psychotherapy for subject's OCD (except maintenance).Subjectsreceiving pre- established concurrent psychotherapy for at least 8 weeks regardingother psychological issues are eligible for enrollment.
  2. New Treatments: Initiation of an antidepressant within 12 weeks before studyenrollment or an antipsychotic 6 weeks before study enrollment. No new alternativemedications, 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 beforestudy enrollment (6 weeks for antipsychotic). Alternative medications must be stablefor 6 weeks prior to baseline. Any medications must remain stable during treatment;consistent with the National Institute of Health (NIH)-funded Child Anxiety MultimodalStudy (CAMS) trial, downward adjustments due to side effects may be acceptable andwill be discussed with the study child and adolescent psychiatrist and the communitypsychiatrist.
  4. Current clinically significant suicidality or individuals who have engaged in suicidalbehaviors 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 hyperactivitydisorder (ADHD), Tourette's syndrome, schizophrenia or schizoaffective disorders
  6. Youth with hoarding symptoms as they may be conceptually and genetically differentfrom 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 tohospitalization during the study.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Transcranial Direct Current Stimulation
Phase:
Study Start date:
January 25, 2021
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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