US College of Medicine develops an Adaptive Deep Brain Stimulation for the Treatment of Intractable Obsessive-Compulsive Disorder

Baylor College of Medicine is about to start the clinical trial of Development of Adaptive Deep Brain Stimulation (aDBS) for the Treatment of Intractable Obsessive-Compulsive Disorder (OCD) Phase II Using Summit RC+S System With ECoG Paddles.

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 and 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 (DBS) 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 DBS 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.

The trial is designed to enroll male and female 18 to 70 years and is being conducted in the University of Pittsburgh, Pittsburgh, Pennsylvania, United States; Brown University, Providence, Rhode Island, United States; Baylor College of Medicine, Houston, Texas, United States.

Among the inclusion conditions appear:

  • Male or female between ages 21 and 70.
  • At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning.
  • A primary diagnosis of OCD with Y-BOCS minimum score of 28.
  • Failed an adequate trial of at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine.
  • Stable psychotropic medical regimen for the month preceding surgery.

The full list can be viewed at the link below.

The study start date is June 1, 2021.

Among the collaborators in this study are University of Pittsburgh, Brown University, Carnegie Mellon University, National Institute of Neurological Disorders and Stroke (NINDS) and Medtronic.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04806516

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