Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation

Обзор

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

Подробное описание

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

Вмешательства

• Устройство Dorsal medial Prefrontal Cortex intermittent theta burst stimulation
  iTBS stimulation of the dmPFC is a FDA-approved treatment for adults with OCD
• Устройство cTBS to ROFC
  continuous theta burst stimulation (cTBS) 1,800 pulses per session

Первичные конечные точки

• Completion rate [Срок оценки: Baseline to completion of all protocol visits, up to 8 weeks]
• Adverse events [Срок оценки: Baseline to completion of all protocol visits up to 8 weeks]

Вторичные конечные точки (2)

• Combined efficacy [Срок оценки: Baseline to completion of all protocol visits, up to 8 weeks]
• Site efficacy [Срок оценки: From screening to end of treatment (Week 4)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Публикации

• 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 PMID 39293504
• 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/ PMID 31109199

Идентификаторы

NCT: NCT07065669 · 24-41216

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗