Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation

NCT07065669 | Recruiting FDA Device

• 1 other identifier: 24-41216
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder

Keywords

Adolescent; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Completion rate

  Proportion (percentage) of all participants who enter the study, undergo a minimum of one TMS treatment, and complete the protocol-specified 15 TMS visits

  Baseline to completion of all protocol visits, up to 8 weeks

• Adverse events

  Frequency (percentage) of individual adverse events

  Baseline to completion of all protocol visits up to 8 weeks

Secondary Outcomes (2)

• Combined efficacy

  Baseline to completion of all protocol visits, up to 8 weeks

• Site efficacy

  From screening to end of treatment (Week 4)

Study Arms (2)

Right Orbitofrontal TBS

EXPERIMENTAL

continuous theta burst stimulation

Device: cTBS to ROFC

TBS of dorsal, medial prefrontal cortex

ACTIVE COMPARATOR

intermittent theta burst stimulation (iTBS) will be delivered to the dmPFC

Device: Dorsal medial Prefrontal Cortex intermittent theta burst stimulation

Interventions

Dorsal medial Prefrontal Cortex intermittent theta burst stimulation DEVICE

iTBS stimulation of the dmPFC is a FDA-approved treatment for adults with OCD

TBS of dorsal, medial prefrontal cortex

cTBS to ROFC DEVICE

continuous theta burst stimulation (cTBS) 1,800 pulses per session

Right Orbitofrontal TBS

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Hearst Foundations: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94107, United States

RECRUITING

Related Publications (2)

• Vicheva P, Osborne C, Krieg SM, Ahmadi R, Shotbolt P. Transcranial magnetic stimulation for obsessive-compulsive disorder and post-traumatic stress disorder: A comprehensive systematic review and analysis of therapeutic benefits, cortical targets, and psychopathophysiological mechanisms. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Jan 10;136:111147. doi: 10.1016/j.pnpbp.2024.111147. Epub 2024 Sep 16.

  PMID: 39293504 BACKGROUND

• Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.

  PMID: 31109199 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• James T McCracken, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Starlette Khim, BA

CONTACT

415-514-5743; ocdteenTMS@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arm, randomized assignment to two types of transcranial magnetic stimulation

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 15, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning one year and ending 3 years after publication of results
• Access Criteria: Qualified researchers who submit a brief description of planned analyses must be submitted to the PI to review and approve data sharing

Locations

US (1)