Individualized Neuroimaging Biomarkers for Predicting rTMS Response in OCD

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study evaluates an accelerated schedule of theta-burst stimulation using a Transcranial Magnetic Stimulation (TMS) device for treatment-resistant Obsessive Compulsive Disorder (OCD). In a randomized fashion, half the participants will receive accelerated theta-burst stimulation at the dorsomedial prefrontal cortex (DMPFC), while half will receive accelerated theta-burst stimulation at the right orbitofrontal (rOFC) site.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OCD with a moderate level of severity as defined by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 18.

• stable on Serotonin Re-uptake Inhibitor (SRI) medication for at least 8 weeks prior to (with plans to continue throughout) the study Note: Medications that are known to increase cortical excitability (e.g., buprorion, maprotiline, tricyclic antidepressants, classical antipsychotics) or to have an inhibitory effect on brain excitability (e.g., anti-convulsants, benzodiazepines, and atypical antipsychotics), or any other medications with relative hazard for use in TMS will be allowed upon review of medications and/or motor threshold determination by TMS specialist.

• failed at least 1 prior trial of standard first-line OCD treatment per American Psychological Association (APA) Practice Guidelines (serotonin reuptake inhibitor \[SRI\] or cognitive behavioral therapy with exposure and response prevention)OR had refused these treatments for individual reasons.

• capacity to provide informed consent.

• ability to tolerate clinical study procedures.

• successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI) without any contraindications.

Locations
United States
California
Department of Psychiatry and Behavioral Sciences, Stanford School of Medicine
RECRUITING
Stanford
Contact Information
Primary
Nick Bassano, MSW
nbassano@stanford.edu
650-497-3933
Time Frame
Start Date: 2021-01-15
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 180
Treatments
Active_comparator: bilateral DMPFC
This arm will receive intermittent theta-burst stimulation to bilateral DMPFC site.
Active_comparator: right OFC
This arm will receive continuous theta-burst stimulation to the right OFC site.
Related Therapeutic Areas
Sponsors
Leads: Stanford University

This content was sourced from clinicaltrials.gov