Transcranial Magnetic Stimulation and Psychotherapy for Treating Obsessive-Compulsive Disorder
NCT ID: NCT07146438
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2025-11-10
2028-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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rTMS+ERP
Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Exposure and Response Prevention (ERP) Therapy
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.
rTMS+ST
Repetitive Transcranial Magnetic Stimulation (rTMS)
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)
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.
Interventions
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Repetitive Transcranial Magnetic Stimulation (rTMS)
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)
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
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
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Adam Frank
OTHER
Responsible Party
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Adam Frank
Assistant Professor of Clinical Psychiatry and the Behavioral Sciences
Principal Investigators
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Adam C. Frank, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Keck School of Medicine of USC
Locations
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University of Southern California Health Sciences Campus
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-24-00659
Identifier Type: -
Identifier Source: org_study_id
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