Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation
Recruiting · NCT07065669 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a pilot study to examine the tolerability, safety and early efficacy of two forms of transcranial magnetic stimulation (TMS) for treating adolescents with Obsessive Compulsive Disorder (OCD) who have experienced limited improvements with usual treatments for OCD in adolescents. The project's primary goal is to examine whether adolescents can complete 3 consecutive weeks of TMS administered 5 days per week, and to describe the type of and how common individual side effects with TMS occur in adolescents with OCD. Participants will: * visit the clinic every weekday for 3 weeks (15 days) to receive TMS treatments * have a brain MRI scan before TMS treatments begins and after finishing all TMS * complete questionnaires and report changes in behavior and physical symptoms
Who can take part
Inclusion criteria
- outpatients
- ages 13 - 17 years
- meets current DSM-5 criteria for Obsessive Compulsive Disorder with screening CY-BOCS II score \> 16 (moderate to severe).
- stable on chronic psychotropic medications and/or therapy for 8 weeks prior to the study and agreeable to continue throughout the study without changes.
- participants may continue to take medications and record daily usage throughout the study.
- capacity to provide informed assent and parent or legal guardian able to provide consent.
- ability to tolerate clinical study procedures.
- successfully complete the screening forms without any contraindications.
Exclusion criteria
- Psychiatric: history of schizophrenia, bipolar disorder, substance/alcohol abuse disorder, current elevated suicide risk, prior psychosurgery, prior ECT.
- Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis, frank brain injury).
- TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk; family history of 1st degree relative with seizure disorder.
- Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension, malnutrition secondary to eating disorder).
- Females who are pregnant or nursing (as determined by a questionnaire and pregnancy test).
- Current and anticipated continued treatment with excluded medication (See prohibited list).
- Inability to complete the research protocol as determined by the Principal Investigator.
Where it is running
1 location listed across 1 US state.
- University of California, San Francisco - San Francisco, California, United States