Deep Brain Stimulation for Obsessive-Compulsive Disorder
(Phase Ib Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen ByWayne K Goodman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 21-70 with severe OCD that hasn't improved after trying many treatments, including cognitive-behavioral therapy and various medications. Participants must have a significant history of OCD symptoms causing distress and dysfunction. They cannot join if they have neurological disorders, high suicide risk, MRI contraindications, psychotic disorders like schizophrenia, or are pregnant.

Inclusion Criteria

I have completed 25 hours of a specific therapy for OCD without success.

I am between 21 and 70 years old.

Your score on the Y-BOCS test must be at least 28.

+13 more

Exclusion Criteria

Pregnant (confirmed by serum pregnancy test on females of child bearing age) or plans to become pregnant in the next 24 months

Non-Implanted Control Subject Exclusion criteria:

Inability or refusal to give informed consent

+11 more

Participant Groups

The study aims to develop an adaptive Deep Brain Stimulation (aDBS) system for patients with hard-to-treat OCD. It involves surgically implanting electrodes in the brain connected to a chest device that sends electrical currents to alter brain function. The Phase Ib will involve implanting the RC+S system in two subjects.

2Treatment groups

Experimental Treatment

Group I: Summit RC+S DBS Implant for OCDExperimental Treatment1 Intervention

all subjects will receive surgical implantation of DBS system

Group II: One Month Blinded Discontinuation PeriodExperimental Treatment1 Intervention

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