Development of Adaptive Deep Brain Stimulation for OCD (NCT04281134)
Development of Adaptive Deep Brain Stimulation (aDBS) for the Treatment of Intractable OCD: Phase Ib Using Summit RC+S
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Pittsburgh — Pittsburgh, Pennsylvania
Age range: 21 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- University of Pittsburgh — Pittsburgh, Pennsylvania
- Brown University — Providence, Rhode Island
- Baylor College of Medicine — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Obsessive-Compulsive Disorder
- Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD — Toronto, Ontario
- Effects of Psilocybin in Obsessive Compulsive Disorder — Baltimore, Maryland
- Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder — Pittsburgh, Pennsylvania
- Personalized DBS for OCD Guided by Stereoencephalography Mapping — San Francisco, California
- Brain Recordings in Patients Undergoing Deep Brain Stimulation (DBS) for Severe Obsessive-Compulsive Disorder (OCD) — Houston, Texas
Explore by condition: All Obsessive-Compulsive Disorder clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.