Transcranial Magnetic Stimulation and Psychotherapy for Treating Obsessive-Compulsive Disorder

Part of paid clinical trials in Los Angeles, California.

Sponsor
Adam Frank
Study ID
NCT07146438
Status
Recruiting

Conditions

  • Obsessive - Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) — DEVICE
    rTMS will be delivered with the MagPro X100 system equipped with a Cool-DB80 coil and a Localite neuronavigation system. Neuronavigation will be performed for anatomical landmarking and co-registration of the brain to Talairach stereotaxic space, with the co-registered coil vertex coordinate (x0, y+60, z+60) as performed in previously published work on dmPFC-rTMS and which represents \~25% of the nasion-inion distance. Posterior coil handle orientation will be used with stimulation parameters of 20Hz repetition rate, 2 second stimulation duration, 20 second inter-train interval, and 50 trains, for a total of 2000 pulses per day. Stimulation will be delivered at 100% of extensor hallucis longus muscle resting motor threshold (MT), as determined by the PI. rTMS will be delivered 5 days per week (Monday through Friday) for 6 weeks for a total of 30 treatment sessions, in keeping with established protocols. Trained research staff will perform daily rTMS treatments and monitor participants.
  • Supportive Therapy (ST) — BEHAVIORAL
    Supportive therapy (ST) is a nondirective "talk therapy" focused on enhancing coping skills, strengthening existing resources, and improving daily functioning. Core techniques will include active listening, encouragement, validation, reframing, clarification (summarizing and paraphrasing), and naming problems. Participants will receive two ST sessions per week during the 6-week rTMS course. General goals include using the therapeutic relationship to foster adaptation, improve self-esteem, and support overall well-being. Each session will last 53-60 minutes and take place concurrently with rTMS, with the participant remaining in the TMS treatment room throughout.
  • Exposure and Response Prevention (ERP) Therapy — BEHAVIORAL
    ERP is a form of cognitive-behavioral therapy designed to reduce obsessive-compulsive symptoms by weakening the association between feared stimuli and maladaptive responses. It promotes the formation and recall of non-threatening associations to counter fear-based learning. The participant and therapist will collaboratively create a hierarchy of OCD triggers, rated using the Subjective Units of Distress Scale (SUDS). ERP will begin with exposures rated 4-7 on the SUDS, while participants refrain from engaging in compulsions. Each trigger will be repeated until the SUDS rating decreases by at least 50% before progressing to the next item. Between-session ERP homework will be assigned, and participants will be provided self-monitoring homework rating forms to complete for subsequent review with the therapist. Each ERP session will last 53-60 minutes and will be conducted concurrently with rTMS, with the participant remaining in the TMS treatment room throughout.

Study Details

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.

Key Dates

Start date
Nov 10, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: rTMS+ERP
  • Placebo Comparator: rTMS+ST

Primary Outcome Measure

Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score [ Time Frame: From enrollment to end of study at 16 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern California Health Sciences CampusLos AngelesCalifornia90033
Frank OCD Lab
323-230-0162
Emma Garland
213-821-3120
Adam C. Frank, MD, PhD (PRINCIPAL_INVESTIGATOR)
Barbara C Van Noppen, PhD (SUB_INVESTIGATOR)
Michelle Dexter, PhD (SUB_INVESTIGATOR)

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