SEEG Guided DBS ON-OFF (Stimulation-Sham) for Obsessive-Compulsive Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obsessive-Compulsive DisorderPMT Stereoencephalography (SEEG) - Device
Eligibility
22 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This is a dual-site, 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 DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.

Eligible Conditions
  • Obsessive-Compulsive Disorder

Treatment Effectiveness

Study Objectives

6 Primary · 0 Secondary · Reporting Duration: Approximately 4 years

14 days
Primary Feasibility Endpoint #1 - OCD Relevant Network
Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms
Approximately 4 years
Primary Safety Endpoint - Serious Adverse Events
Approximately 60 weeks
Primary Feasibility Endpoint #4 - Acute Symptomatic Improvement
Day 14
Primary Feasibility Endpoint #3 - Willingness to Continue with DBS Stage 2
Up to 24 weeks
Primary Efficacy Endpoint - Treatment Response

Trial Safety

Trial Design

2 Treatment Groups

SEEG Guided DBS ON-OFF (Stimulation-Sham)
1 of 2
SEEG Guided DBS OFF-ON (Sham-Stimulation)
1 of 2

Experimental Treatment

Non-Treatment Group

10 Total Participants · 2 Treatment Groups

Primary Treatment: SEEG Guided DBS ON-OFF (Stimulation-Sham) · Has Placebo Group · N/A

SEEG Guided DBS ON-OFF (Stimulation-Sham)Experimental Group · 2 Interventions: PMT Stereoencephalography (SEEG), Vercise Genus™ Deep Brain Stimulation (DBS) System · Intervention Types: Device, Device
SEEG Guided DBS OFF-ON (Sham-Stimulation)ShamComparator Group · 2 Interventions: PMT Stereoencephalography (SEEG), Vercise Genus™ Deep Brain Stimulation (DBS) System · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 4 years

Who is running the clinical trial?

Casey H. Halpern, M.D.Lead Sponsor
University of California, San FranciscoOTHER
2,283 Previous Clinical Trials
11,577,644 Total Patients Enrolled

Eligibility Criteria

Age 22 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 22 years old and at least 65 years old.
You have OCD, which is a chronic mental disorder that causes excessive thoughts, feelings, and behaviors.
You have a time-consuming obsession or compulsion that takes more than one hour a day or causes clinically significant distress or impairment in social, occupational, or other important areas of functioning.
You have obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g.
You have a history of 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.
The medication was given for a minimum of 1 month and a maximum of 6 months.