Adaptive DBS for Obsessive-Compulsive Disorder
What You Need to Know Before You Apply
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.Phase Ia is to gather data to eventually develop a prototype adaptive DBS system for intractable OCD that uses signals from the brain to automatically adjust the DBS stimulation factors. The overall goal is to improve symptom management and reduce stimulation-induced behavioral side effects.
Will I have to stop taking my current medications?
The trial requires that participants have a stable psychotropic medication regimen for the month before surgery, so you may need to continue your current medications if they are stable. The protocol does not specify stopping any medications.
Is adaptive DBS 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. In a study with 30 patients, all experienced side effects, but the majority were not severe and were related to the device's programming or stimulation.12345
How is the Adaptive DBS treatment for OCD different from other treatments?
Adaptive DBS (deep brain stimulation) for OCD is unique because it involves implanting a device that delivers electrical stimulation to specific brain areas, such as the ventral part of the anterior limb of the internal capsule, to reduce symptoms. This approach is different from traditional treatments like medication or therapy, as it directly targets brain circuits involved in OCD, offering hope for patients who do not respond to other treatments.56789
What data supports the effectiveness of the treatment Activa PC+S DBS implant for OCD?
Who Is on the Research Team?
Wayne K Goodman, MD
Principal Investigator
Baylor College of Medicine
Are You a Good Fit for This Trial?
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 impairment, not be at high risk of suicide or impulsivity, and cannot have other major neurological conditions or be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo a single stage DBS surgery, followed by post-operative evaluations and device programming
Post-surgical Monitoring
Participants return to clinic every 2 weeks for the first 2 months following system activation for assessments and recordings
CBT Augmentation
Participants receive a two-month cognitive behavioral therapy course starting at Month 7
Double Blinded Discontinuation
One-month blinded discontinuation period to confirm clinical benefit
Monthly Programming/Classification/Evaluation
Monthly visits for programming and evaluation from Month 10 to 18
Long-Term Follow-Up
Device remains implanted for subjects doing well clinically, with follow-up management arranged on a case-by-case basis
What Are the Treatments Tested in This Trial?
Interventions
- Activa PC+S DBS implant for OCD
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Brown University
Collaborator
University of Pittsburgh
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
Carnegie Mellon University
Collaborator