A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Four-Lead Personalized Deep Brain Stimulation for Treatment-Refractory Obsessive Compulsive Disorder (SEEG-Guided DBS for OCD)

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

This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: f
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• ≥ 22 years and ≤ 75 years of age, at the time of screening

• Chronic (\> 5 years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)

∙ Presence of obsessions, compulsions, or both

‣ Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning

‣ Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g. a drug of abuse, a medication) or another medical condition

‣ Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5

• Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment

• Lack of adequate response to a history of all the following treatments, based on information from any of the following: (a) the current treating physician and/or psychologist; (b) medical records or other forms of communication from previous healthcare providers; and (c) pharmacy records, as determined by the Principal Investigator (PI). Patients may continue to be receiving these following treatments while still enrolled in the study.

∙ Adequate trial of ≥ 2 selective serotonin reuptake inhibitors (SSRIs) for an adequate duration at the maximum dose recommended for OCD or at the maximally-tolerated dose according to the FDA-approved package labeling

‣ Adequate trial of ≥ 1 augmentation trial using an antipsychotic medication

‣ Adequate trial of clomipramine, either as monotherapy or as an augmentation therapy, unless medically contradicted

‣ Adequate trials of cognitive behavior therapy-based Exposure and Response Prevention (ERP)

‣ Has not responded adequately to TMS treatment for OCD if it is reasonably available to the patient

• Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least 8 weeks prior to study enrollment and for the duration of the trial, in the opinion of the Principal Investigator

• Study participation in the prospective subject's best psychiatric interest, as determined by the research/study psychiatrist and based on a comprehensive assessment that includes the following: (a) detailed psychiatric history; (b) examination of the mental status; (c) review of psychiatric assessment measures obtained to determine eligibility, as applicable; (d) review of previous medical records for a minimum of 2 years prior to enrollment, or as applicable; and (e) consideration of the potential benefits versus risks of study participation

• Agreement to being evaluated by a licensed psychiatrist and/or psychologist at regular intervals of every 3 months for the duration of study participation

• Adequate social support, including but not limited to, stable housing and two family members and/or friends, who are identified as a verifiable emergency contacts

• Willingness and ability to provide at least two verifiable contacts for emergency purposes and to permit verification of emergency contacts by research staff before all study visits and as needed, at the discretion of the Principal Investigator

⁃ Ability to understand procedure-related instructions and to complete study assessments in English, in the opinion of the Principal Investigator

⁃ Willingness and ability to comply with protocol requirements (e.g. procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), in the opinion of the Principal Investigator

⁃ Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s)

⁃ Willingness and ability to provide informed consent, in the opinion of the Principal Investigator

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Tenzin Norbu, BS
ocdresearch@ucsf.edu
415-885-7707
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2028-05
Participants
Target number of participants: 10
Treatments
Experimental: ON-OFF (Stimulation-Sham)
Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period.
Experimental: OFF-ON (Sham-Stimulation)
Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point.
Sponsors
Leads: Andrew Moses Lee, MD, PhD

This content was sourced from clinicaltrials.gov