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| Name | Class |
|---|---|
| Hearst Foundations | UNKNOWN |
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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:
This study's primary goal is to examine whether treatment with two forms of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) show acceptable tolerability, safety, and preliminary signals of efficacy for adolescents with Obsessive Compulsive Disorder (OCD) that has not responded satisfactorily to 1st line treatments. While TMS is FDA-approved for OCD in adults, data on TMS in youth with OCD is limited. Results will inform on how suitable TMS treatment is for adolescents with OCD, and guide future, larger studies.
The study is considered a randomized, single blind, clinical trial.
The design of the study is a two-group parallel comparative study of two different TMS stimulation sites, the orbito-frontal cortex (OFC) and the dorsal medial prefrontal cortex (dmPFC).
Model description: both groups will receive active TMS treatment sessions in clinic every weekday for 3 consecutive weeks (15 days). During each TMS session, participants in both groups will receive 3 TMS stimulations separated by a rest period, for a total of 45 individual TMS treatments. Study participants will receive TMS to only their assigned stimulation site.
Number of arms: there are two treatment arms based on assigned treatment site, an OFC arm and a dmPFC arm.
Masking: an independent evaluator will be masked to treatment arm assignment and adverse events. All other study personnel will not be masked.
Allocation: participants will be randomly assigned to group according to a computer-generated assignment schedule.
Enrollment: total planned enrollment is 30 eligible participants who are randomized.
Arm Information:
Arm titles-- orbitofrontal cortex (OFC) and dorsal medial prefrontal cortex (dmPFC) Arm types: the dmPFC arm is considered the intervention arm; the OFC arm is considered the active comparator arm.
Interventions:
Intervention type: Device (both arms)
Intervention name(s):
OFC - continuous theta burst stimulation (cTBS) dmPFC - intermittent theta burst stimulation (iTBS)
Intervention description:
OFC - three stimulations per day of 1,800 pulses/stimulation cTBS for 15 days dmPFC - three stimulations per day of 1,800 pulses/session iTBS for 15 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right Orbitofrontal TBS | Experimental | continuous theta burst stimulation |
|
| TBS of dorsal, medial prefrontal cortex | Active Comparator | intermittent theta burst stimulation (iTBS) will be delivered to the dmPFC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dorsal medial Prefrontal Cortex intermittent theta burst stimulation | Device | iTBS stimulation of the dmPFC is a FDA-approved treatment for adults with OCD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Combined efficacy | Change in independent assessor-rated CY-BOCS II total score | Baseline to completion of all protocol visits, up to 8 weeks |
| Site efficacy | Compare changes in blinded clinician CY-BOCS II total by TMS site (OFC vs dmPFC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Starlette Khim, BA | Contact | 415-514-5743 | ocdteenTMS@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| James T McCracken, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39293504 | Background | 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. | |
| 31109199 |
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IPD to be shared will include both primary endpoint data and secondary endpoint data.
Beginning one year and ending 3 years after publication of results
Qualified researchers who submit a brief description of planned analyses must be submitted to the PI to review and approve data sharing
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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Two arm, randomized assignment to two types of transcranial magnetic stimulation
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| cTBS to ROFC | Device | continuous theta burst stimulation (cTBS) 1,800 pulses per session |
|
| From screening to end of treatment (Week 4) |
| 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. |