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

  • STATUS
    Recruiting
  • End date
    Mar 11, 2023
  • participants needed
    36
  • sponsor
    Massachusetts General Hospital
Updated on 11 April 2021

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).

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.

Details
Condition Obsessive-Compulsive Disorder, ANXIETY NEUROSIS, Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Disorders, obsessive compulsive disorder, childhood psychiatric disorders
Treatment Transcranial Direct Current Stimulation
Clinical Study IdentifierNCT04548609
SponsorMassachusetts General Hospital
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 IQ85 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

Exclusion Criteria

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
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