Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder

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 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.

This current research protocol will focus on the completion of Phase II which will implant the RC+S system with ECoG paddles in 5 subjects.

Conditions

• Obsessive-Compulsive Disorder

Interventions

DEVICE

Summit RC+S System with ECoG Paddles

Summit RC+S System with ECoG Paddles consists of: * Olympus RC+S implantable pulse generator (IPG), Model B35300R: 2 per subject x 5 subjects = 10 units * Extension Leads, Model 37087: 2 per subject X 5 subjects = 10 units * DBS Leads, Model 3387: 2 per subject X 5 subjects = 10 units * Patient Therapy Manager (PTM), Model 4NR009: 1 per subject x 5 subjects = 5 units * Recharge Therapy Manager (RTM), Model 97755: 1 per subject x 5 subjects = 5 units * Clinician Telemetry Module (CTM), Model 4NR011: 1 per subject x 5 subjects = 5 units * Research Lab Programmer (RLP), Model 4NR010: 1 unit * Research Software Development Kit (RDK), Model 4NR013: 2 units * Subdural Quadripolar Paddle Lead, Model 09130: 2 per subject x 5 subjects = 10 units

OTHER

One Month Blinded Discontinuation Period:

The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline.

Sponsors & Collaborators

• University of Pittsburgh

  collaborator OTHER

• Brown University

  collaborator OTHER

• Carnegie Mellon University

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Medtronic

  collaborator INDUSTRY

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Wayne Goodman, MD · Baylor College of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2026-07-30

Completion

2026-07-30

FDA Device

Yes

Countries

• United States

Study Locations