Adaptive DBS for Obsessive-Compulsive Disorder

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. 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.

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 impairment, not be at high risk of suicide or impulsivity, and cannot have other major neurological conditions or be pregnant.

Inclusion Criteria

My OCD wasn't helped by adding antipsychotics to my treatment.

I am between 21 and 70 years old.

I have had OCD for over 5 years, and treatments haven't worked well for me.

+11 more

Exclusion Criteria

I only have Essential Tremor and no other neurological conditions or brain injuries.

Non-Implanted Control Subject Exclusion criteria: Contraindications to MRI

I am not pregnant.

+17 more

Participant Groups

The study tests an adaptive Deep Brain Stimulation (aDBS) system in patients with hard-to-treat OCD. It involves surgically placing electrodes in the brain to regulate abnormal activity. The goal is to improve symptom management and reduce side effects by adjusting stimulation based on brain signals.

2Treatment groups

Experimental Treatment

Group I: One Month Blinded Discontinuation PeriodExperimental Treatment1 Intervention

all subjects will enter a one-month blinded discontinuation period to confirm clinical benefit at the end of Month 8.

Group II: Activa PC+S DBS implant for OCDExperimental Treatment1 Intervention

all subjects will receive surgical implantation of DBS system