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NCT04281134 · ClinicalTrials.gov registry record · NA
Development of Adaptive Deep Brain Stimulation for OCD
A NA study of Obsessive - Compulsive Disorder, sponsored by Baylor College of Medicine.
- Active
- Registry status
- NA
- Development phase
- 3
- Enrollment target
- 3
- Study locations
NCT04281134 is a NA study of Obsessive - Compulsive Disorder that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 3 participants, below the 2,065-participant average among 84 other Obsessive - Compulsive Disorder trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04281134, a NA study of Obsessive - Compulsive Disorder, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER One Month Blinded Discontinuation Period:
- DEVICE Summit RC+S System
Study Locations (3)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Rhode Island
- Brown University - Providence
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-10-11 |
| Est. Completion | 2026-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04281134
The ClinicalTrials.gov registry entry for NCT04281134 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,065-participant average among 84 other Obsessive - Compulsive Disorder trials with a reported enrollment target (100% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obsessive - Compulsive Disorder appearing as the primary indexed condition, and to 2 interventions - of which One Month Blinded Discontinuation Period: is the first listed.
NCT04281134 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Pennsylvania, Rhode Island, Texas.
Frequently Asked Questions
What is clinical trial NCT04281134 about?
NCT04281134 is a clinical study titled "Development of Adaptive Deep Brain Stimulation for OCD". 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 pop...
What is the current status of trial NCT04281134?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 3 participants. The study started on 2019-10-11. Estimated completion is 2026-06.
What conditions does trial NCT04281134 study?
This clinical trial studies the following conditions: Obsessive - Compulsive Disorder.
What interventions are being tested in trial NCT04281134?
The interventions under investigation include: One Month Blinded Discontinuation Period: (OTHER), Summit RC+S System (DEVICE).
Who is sponsoring clinical trial NCT04281134?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04281134 being conducted?
This trial has 3 study locations across Pennsylvania, Rhode Island, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Related
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