Development of Adaptive Deep Brain Stimulation for OCD
NCT: NCT04281134 · ACTIVE_NOT_RECRUITING
Brief Summary
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.
Frequently Asked Questions
What is Development of Adaptive Deep Brain Stimulation for OCD?
Development of Adaptive Deep Brain Stimulation for OCD is a clinical trial registered under NCT04281134. Current status: ACTIVE_NOT_RECRUITING.
What is the status of NCT04281134?
The current status of NCT04281134 (Development of Adaptive Deep Brain Stimulation for OCD) is: ACTIVE_NOT_RECRUITING.
When did Development of Adaptive Deep Brain Stimulation for OCD start?
Development of Adaptive Deep Brain Stimulation for OCD started on 2019-10-11.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.