Phase
Condition
Holoprosencephaly
Anxiety Disorders
Autism
Treatment
Transcranial Direct Current Stimulation
Clinical Study ID
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 TheSchedule for Affective Disorders and Schizophrenia for School-Age Children- Computeradministered version (KSADS-COMP) based on all available information.
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.
English speaking.
Exclusion
Exclusion Criteria:
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.
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.
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 AnxietyMultimodal Study (CAMS) trial, downward adjustments due to side effects may beacceptable and will be discussed with the study child and adolescent psychiatristand the community psychiatrist.
Current clinically significant suicidality or individuals who have engaged insuicidal behaviors within 6 months will be excluded and referred for appropriateclinical care.
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
Youth with hoarding symptoms as they may be conceptually and genetically differentfrom other OCD subtypes.
BMI less than 18.5.
Contraindication to tDCS: history or epilepsy, metallic implants in the head andneck, 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 tohospitalization during the study.
Study Design
Study Description
Connect with a study center
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available

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