Transcranial Magnetic Stimulation and Psychotherapy for Treating Obsessive-Compulsive Disorder

Adam Frank

Status: Enrolling

Conditions: Obsessive - Compulsive Disorder

Treatments: Behavioral: Supportive Therapy (ST); Behavioral: Exposure and Response Prevention (ERP) Therapy; Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07146438

HS-24-00659

Details and patient eligibility

About

This study will test how people with OCD respond to a type of noninvasive brain stimulation, repetitive Transcranial Magnetic Stimulation (rTMS), when it is combined with psychotherapy. Participants will either engage in Exposure and Response Prevention (ERP) Therapy or supportive therapy (ST) while receiving rTMS. Biobehavioral data from wearable devices and smartphones will be collected to better predict treatment responses. Participants will also undergo repeat resting state functional Magnetic Resonance Imaging (rsfMRI) in order to assess neural predictors and mechanisms of treatment response.

Full description

This is a randomized, controlled pilot study to evaluate the feasibility, tolerability, and preliminary effects of combining repetitive transcranial magnetic stimulation (rTMS) with one of two types of therapy for adults with Obsessive-Compulsive Disorder (OCD). All participants will receive rTMS targeted to a specific brain area (the dorsomedial prefrontal cortex/anterior cingulate cortex) five days per week (Monday through Friday) for six weeks, utilizing the FDA-cleared treatment protocol. In addition, participants will receive either Exposure and Response Prevention (ERP), a form of cognitive behavioral therapy, or supportive therapy (ST), delivered virtually twice per week during the rTMS treatment period.

The study lasts a total of 16 weeks. During the first week, participants will complete baseline assessments, including questionnaires about symptoms, functioning, quality of life, and treatment priorities. Participants will undergo a brain scan (rsfMRI) and receive a Fitbit device (Charge 6) to wear throughout the study. Participants will also be guided on how to complete daily self-report check-ins using their smartphone. These check-ins, along with the Fitbit, will collect information about behavior (e.g., sleep, physical activity), physiology (e.g., heart rate), and lived experience (e.g., stress, mood, and symptoms) throughout the study period.

rTMS treatment begins in week 2 and continues for six weeks. ERP or supportive therapy sessions are scheduled twice per week, on the same days as rTMS (Tuesdays and Thursdays), and take place while participants are receiving rTMS in the treatment room. Weekly assessments of OCD symptom severity will be conducted throughout the six-week treatment phase.

After the treatment phase ends in week 8, participants will repeat the brain scan and complete final symptom and functioning assessments. At this time, Fitbit data collection and daily surveys will cease. At week 16 (two months after treatment ends), participants will complete a follow-up assessment to evaluate longer-term outcomes.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Obsessive-Compulsive Disorder (OCD) as determined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria.
• Live in Southern California and be willing to attend in-person to receive repetitive Transcranial Magnetic Stimulation (rTMS) 5 times per week for 6 weeks.
• Have completed a prior course of Exposure and Response Prevention (ERP) therapy (at least ten sessions)
• Currently take or have previously tried Serotonin Reuptake Inhibitor (SRI) medication for OCD
• Willing to maintain psychotropic medication levels throughout the 16 weeks of the study

Exclusion criteria

• Primary psychiatric diagnosis other than OCD
• Active substance use disorder
• Active suicidality
• Active psychosis
• History of seizures
• Severe neurological impairment
• Pregnant or planning to become pregnant
• Received a prior rTMS course

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

rTMS+ERP

Active Comparator group

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Behavioral: Exposure and Response Prevention (ERP) Therapy

rTMS+ST

Placebo Comparator group

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Behavioral: Supportive Therapy (ST)