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Device
Deep Brain Stimulation for Obsessive-Compulsive Disorder
N/A
Recruiting
Research Sponsored by Casey H. Halpern, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights
Study Summary
This trial will study a new type of brain stimulation to treat OCD that hasn't responded to other treatments. It involves 3 stages: mapping, surgery, & randomized trial before open label use.
Who is the study for?
This trial is for adults aged 22-65 with severe, treatment-resistant Obsessive-Compulsive Disorder (OCD), having tried multiple medications and cognitive therapy without success. Participants must be able to follow the study's procedures in English, live within a 6-hour drive of the study sites, have stable housing and support, and commit to no psychotherapy or medication changes during the trial.Check my eligibility
What is being tested?
The trial tests SEEG-guided Deep Brain Stimulation (DBS) using Vercise Genus™ System on those with severe OCD. It involves brain mapping, DBS surgery, parameter optimization, randomized crossover treatment phases followed by open label stimulation over approximately an 18-month period.See study design
What are the potential side effects?
Potential side effects may include discomfort at implantation sites, headache or dizziness post-surgery; risk of infection; possible changes in mood or behavior; unintended movements; speech disturbances; sensory issues like tingling or numbness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Efficacy Endpoint - Treatment Response
Primary Feasibility Endpoint #1 - OCD Relevant Network
Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SEEG Guided DBS ON-OFF (Stimulation-Sham)Experimental Treatment2 Interventions
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.
Group II: SEEG Guided DBS OFF-ON (Sham-Stimulation)Placebo Group2 Interventions
Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point.
Find a Location
Who is running the clinical trial?
Stanford UniversityOTHER
2,395 Previous Clinical Trials
17,341,345 Total Patients Enrolled
15 Trials studying Obsessive-Compulsive Disorder
1,393 Patients Enrolled for Obsessive-Compulsive Disorder
Casey H. Halpern, M.D.Lead Sponsor
University of California, San FranciscoOTHER
2,506 Previous Clinical Trials
15,238,545 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have completed a full course of ERP therapy for my condition.I have not been treated for drug or alcohol abuse in the last 2 years.I am between 22 and 75 years old.My obsessive-compulsive symptoms are not due to drugs or other health issues.I have tried at least 2 SSRIs for OCD at the highest dose I can tolerate.I agree to let my doctors and the research team share information about my care.I have tried at least one antipsychotic medication to improve my condition.I experience strong obsessions or compulsions.I am willing to stop my therapy sessions if the study's psychiatrist agrees.I have tried clomipramine alone or with other treatments, unless it was unsafe for me.I have had a serious head injury or multiple concussions in the past 2 years.I have been diagnosed with a specific mental health condition by a psychiatrist.
Research Study Groups:
This trial has the following groups:- Group 1: SEEG Guided DBS ON-OFF (Stimulation-Sham)
- Group 2: SEEG Guided DBS OFF-ON (Sham-Stimulation)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants aged 40 or above eligible for this trial?
"The requirement for candidacy in this scientific investigation is to be between 22 and 65 years old."
Answered by AI
Who is eligible to join this clinical trial?
"This clinical trial is welcoming 10 participants that suffer from obsessive-compulsive disorder and are between 22 to 65 years of age."
Answered by AI
Are researchers still enrolling participants for this clinical trial?
"Data posted on clinicaltrials.gov suggests that this medical study is no longer recruiting patients, with the initial posting date being December 1st 2022 and the last update occuring November 14th 2022. However, as of now there are 114 different studies actively accepting participants."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
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