Adaptive DBS for Obsessive-Compulsive Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method of using deep brain stimulation (DBS) to assist individuals with severe Obsessive-Compulsive Disorder (OCD) who have not found relief from other treatments. DBS involves placing a device in the brain that sends electrical signals to manage OCD symptoms. The goal is to develop a system that automatically adjusts these signals based on brain activity, aiming to improve symptom control and reduce side effects. Ideal participants are those who have struggled with OCD for at least five years without relief from medications or therapy. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to innovative OCD treatment options.
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.
What prior data suggests that this adaptive DBS system is safe for treating OCD?
Research has shown that deep brain stimulation (DBS) is a safe treatment for individuals with hard-to-treat obsessive-compulsive disorder (OCD). One study found that DBS was effective and manageable for patients with severe OCD, resulting in positive long-term outcomes. Another study on DBS safety confirmed its safety across various locations, with patients generally coping well. Reports so far indicate that DBS can help without causing major side effects, making it a promising option for those with severe OCD.12345
Why are researchers excited about this trial?
Unlike the standard treatments for obsessive-compulsive disorder (OCD), which often involve medications like SSRIs or cognitive-behavioral therapy, the Activa PC+S DBS implant takes a different approach. This treatment uses deep brain stimulation (DBS), a technique that involves delivering electrical impulses directly to specific areas of the brain. Researchers are excited because DBS offers a targeted method to potentially regulate brain activity and alleviate OCD symptoms more effectively, especially in patients who haven't responded to conventional therapies. Moreover, this adaptive DBS system can be adjusted based on the patient's needs, potentially providing a more personalized and responsive treatment option.
What evidence suggests that this adaptive DBS system is effective for OCD?
Research has shown that deep brain stimulation (DBS) can be a safe and effective treatment for people with severe OCD who haven't improved with other treatments. Studies have found that DBS can greatly reduce OCD symptoms, even in those who have had the disorder for many years. One study found that patients experienced a strong decrease in symptoms over more than six years on average. Another study showed that patients generally tolerated DBS well, with few experiencing serious side effects. Overall, evidence suggests that DBS could help manage OCD symptoms when other methods don't work. In this trial, all participants will receive the Activa PC+S DBS implant for OCD, followed by a one-month blinded discontinuation period to confirm clinical benefit.12567
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