Development of Adaptive Deep Brain Stimulation for OCD

Description

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. Phase Ia is to gather data to eventually develop a prototype adaptive DBS system for intractable OCD that uses signals from the brain to automatically adjust the DBS stimulation factors. The overall goal is to improve symptom management and reduce stimulation-induced behavioral side effects.

Study Start Date

March, 01 2018

Estimated Completion Date

June 2023

Interventions

  • Device: Activa PC+S DBS implant for OCD
  • Other: One Month Blinded Discontinuation Period

Study ID

Baylor College of Medicine -- H40255

Status

Recruiting

Trial ID

NCT03457675

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

2

Sponsor

Baylor College of Medicine

Inclusion Criteria

  • DBS Inclusion criteria: 1. Signed informed consent prior to any study specific procedures being performed 2. Male or female between ages 21 and 70
  • 3. At least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning 4. Y-BOCS minimum score of 28 5. Failed an adequate trial of at least three of the following SSRIs: Fluoxetine fluvoxamine citalopram escitalopram sertraline paroxetine 6. Failed an adequate trial of clomipramine 7. Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol risperidone quetiapine ziprasidone aripiprazole 8. Failed an adequate trial of CBT for OCD, defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist 9. Stable psychotropic medical regimen for the month preceding surgery
  • Control Inclusion criteria: 1. Signed informed consent prior to any study specific procedures being performed 2. Male or female between ages 21 and 70

Exclusion Criteria

  • DBS Exclusion criteria: 1. Inability or refusal to give informed consent. 2. Lifetime diagnosis of psychotic disorders such as schizophrenia
  • 3. Alcohol or substance abuse/dependence within 6 months, excluding nicotine 4. Deemed at high risk of suicidal behavior or impulsivity, per clinical opinion assessments. 5. Any Neurological/Medical condition that makes the subject, in the opinion of the surgeon, a poor candidate. 6. Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months. 7. Need for Diathermy
  • Control Exclusion criteria: 1. Inability or refusal to give informed consent. 2. Lifetime diagnosis of mental illness 3. Pregnant (confirmed by serum pregnancy test on females of child bearing age)

Gender

All

Ages

21 Years to 70 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Brown University - Providence, Rhode Island 104.8 miles None None None
University of Pittsburgh - Pittsburgh, Pennsylvania 354.9 miles None None None
Baylor College of Medicine - Houston, Texas 1,475.7 miles Gregory Vogt 713-798-4729 gsvogt@bcm.edu

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