Transcranial Magnetic Stimulation and Psychotherapy for Treating Obsessive-Compulsive Disorder

Official title

Precision Medicine for OCD - Biobehavioral Tracking of Transcranial Magnetic Stimulation (TMS) With Exposure and Response Prevention (ERP) for Refractory OCD

Overview

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.

Detailed 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.

Interventions

• Device 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
• Behavioral 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 su
• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (7)

• Resting state functional connectivity [Time frame: From enrollment to the end of treatment at 8 weeks.]
• Recruitment rate [Time frame: From screening to enrollment.]
• Adverse and serious adverse event rates [Time frame: From enrollment to end of study at 16 weeks.]
• Study dropout rate [Time frame: From enrollment to end of study at 16 weeks.]
• Stanford Expectations of Treatment Scale (SETS) [Time frame: Assessed at study start; 1 session.]
• Self-report priorities in treatment [Time frame: Assessed at study start; 1 session.]
• Fidelity of Adherence to Therapy [Time frame: From start of therapy at week 2 to end of therapy at end of week 7.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Southern California Health Sciences Campus — Los Angeles

Identifiers

NCT: NCT07146438 · HS-24-00659

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗