Transcranial Magnetic Stimulation and Psychotherapy for Treating Obsessive-Compulsive Disorder
Precision Medicine for OCD - Biobehavioral Tracking of Transcranial Magnetic Stimulation (TMS) With Exposure and Response Prevention (ERP) for Refractory OCD
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 28, 2025
CompletedStudy Start
First participant enrolled
November 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
October 27, 2025
September 1, 2025
2.6 years
August 20, 2025
October 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score
The investigators will use the Yale-Brown Obsessive-Compulsive Scale (YBOCS), the gold standard measure of OCD severity, to assess symptom levels. The YBOCS scale assesses five domains of obsessive and compulsive symptoms, which are each scored on a four-point scale, with 0 being "no symptoms" and 4 being "extreme symptoms". Combined scores range from 0 (no symptoms) to 40 (severe symptoms). A trained clinician, blinded to participant treatment, will administer the YBOCS at study enrollment, weekly during rTMS, at study end, and at 2-month follow-up to determine rate of change of YBOCS score, overall change after treatment, and durability of change at follow-up. Greater decreases in YBOCS scores sustained over time represent a better outcome.
From enrollment to end of study at 16 weeks.
Secondary Outcomes (7)
Resting state functional connectivity
From enrollment to the end of treatment at 8 weeks.
Recruitment rate
From screening to enrollment.
Adverse and serious adverse event rates
From enrollment to end of study at 16 weeks.
Study dropout rate
From enrollment to end of study at 16 weeks.
Stanford Expectations of Treatment Scale (SETS)
Assessed at study start; 1 session.
- +2 more secondary outcomes
Study Arms (2)
rTMS+ERP
ACTIVE COMPARATORrTMS+ST
PLACEBO COMPARATORInterventions
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) 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adam Franklead
Study Sites (1)
University of Southern California Health Sciences Campus
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam C. Frank, MD, PhD
Keck School of Medicine of USC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants will know which treatment group they are in but will be blinded to study hypothesis.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Psychiatry and the Behavioral Sciences
Study Record Dates
First Submitted
August 20, 2025
First Posted
August 28, 2025
Study Start
November 10, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
October 27, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share