Deep Brain Stimulation for Obsessive-Compulsive Disorder
(Phase Ib Trial)
Trial Summary
What is the purpose of this trial?
This research study is for participants that have been diagnosed with intractable Obsessive -compulsive disorder (OCD). OCD is a persistent and oftentimes disabling disorder marked by unwanted and distressing thoughts (obsessions) and irresistible repetitive behaviors. OCD affects 2-3% of the US population, and is responsible for substantial functional impairment and increased risk of early death. The only established first-line treatments for OCD are cognitive-behavioral therapy (CBT) with exposure/response prevention and certain medications. About 30-40% of patients fail to respond and few experience complete symptom resolution. Up to 25% of patients have difficulty tolerating CBT and the risk of relapse after therapies remains large. For the most severe cases, neurosurgery (surgery in the brain), has long been the option of last resort. In this study the investigators want develop an adaptive Deep Brain Stimulation (aDBS) system to use in subjects with intractable (hard to control) OCD. Deep brain stimulation remains investigational for OCD patients and is not considered standard therapy. DBS involves the surgical implantation of leads and electrodes into specific areas of the brain, which are thought to influence the disease. A pack implanted in the chest, called the neurotransmitter, keeps the electrical current coursing to the brain through a wire that connects the neurotransmitter and electrodes. It is believed deep brain stimulation may restore balance to dysfunctional brain circuitry implicated in OCD. The goal of this study is to enhance current approaches to DBS targeting in the brain and to use a novel approach to find a better and more reliable system for OCD treatment. This current research protocol will focus on the completion of Phase Ib which will implant the RC+S system in 2 subjects.
Will I have to stop taking my current medications?
The trial requires that participants have a stable medication regimen for at least one month before surgery, so you may not need to stop your current medications if they are stable. However, it's best to discuss your specific situation with the study team.
What data supports the effectiveness of the treatment Summit RC+S System for Obsessive-Compulsive Disorder?
Research shows that deep brain stimulation (DBS) can reduce the severity of symptoms and improve overall functioning in people with severe OCD who do not respond to other treatments. Studies have found DBS to be a promising option for those with treatment-resistant OCD, particularly when targeting specific brain areas like the subthalamic nucleus.12345
Is deep brain stimulation generally safe for humans?
Deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) has been studied for safety, showing that while some serious side effects can occur, most are mild or moderate and often resolve with adjustments. Common issues include anxiety and mood changes, but these are usually temporary. Serious surgery-related problems like bleeding or infection are rare.26789
How is the Summit RC+S System treatment different from other treatments for obsessive-compulsive disorder?
The Summit RC+S System uses deep brain stimulation (DBS), which involves implanting electrodes in specific brain areas to help manage severe OCD symptoms when other treatments have failed. This approach is unique because it directly targets brain circuits involved in OCD, offering a potential option for those who do not respond to conventional therapies.2341011
Research Team
Wayne K Goodman, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for adults aged 21-70 with severe OCD that hasn't improved after trying many treatments, including cognitive-behavioral therapy and various medications. Participants must have a significant history of OCD symptoms causing distress and dysfunction. They cannot join if they have neurological disorders, high suicide risk, MRI contraindications, psychotic disorders like schizophrenia, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo DBS implantation and initial programming, including pre-surgical imaging and post-operative monitoring
Blinded Discontinuation
One month period where DBS is gradually reduced and then turned off to assess effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Summit RC+S System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
Carnegie Mellon University
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc
University of Pittsburgh
Collaborator
Brown University
Collaborator