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Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation

ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorUniversity of California, San Francisco

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dorsal medial Prefrontal Cortex intermittent theta burst stimulation

    Device

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

  • cTBS to ROFC

    Device

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Right Orbitofrontal TBSExperimental treatment 1 intervention
Group B: TBS of dorsal, medial prefrontal cortexActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline to completion of all protocol visits, up to 8 weeks
2

Adverse events

Frequency (percentage) of individual adverse events

Time frame
Baseline to completion of all protocol visits up to 8 weeks

Secondary outcomes

1

Combined efficacy

Change in independent assessor-rated CY-BOCS II total score

Time frame
Baseline to completion of all protocol visits, up to 8 weeks
2

Site efficacy

Compare changes in blinded clinician CY-BOCS II total by TMS site (OFC vs dmPFC)

Time frame
From screening to end of treatment (Week 4)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Hearst Foundations

Collaborator

Source ClinicalTrials.gov
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