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Procedure

Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A

Waitlist Available

Led By Nader Pouratian, M.D., Ph.D.

Research Sponsored by Nader Pouratian

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria

Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment

Must not have

Diagnosis of severe major depression disorder (MDD) with psychotic features

Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study if deep brain stimulation (DBS) can effectively treat severe cases of obsessive-compulsive disorder (OCD). The researchers will investigate the effects of stimulating a specific area of the

Who is the study for?

This trial is for individuals with severe Obsessive-Compulsive Disorder (OCD) that hasn't improved with standard treatments. Participants will undergo surgery to implant a deep brain stimulation device and must commit to follow-up visits every three weeks, plus long-term check-ups for 2-3 years after the first year.

What is being tested?

The study tests if activating certain brain areas with Medtronic Percept Deep Brain Stimulation Therapy improves OCD symptoms compared to sham (fake) stimulation. It also involves mapping brain activity related to symptom severity during and after surgery.

What are the potential side effects?

Potential side effects may include risks associated with brain surgery, such as infection or bleeding, changes in mood or behavior due to stimulation, headache, discomfort at the device site, and possible equipment malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with obsessive-compulsive disorder.

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My OCD has been severe and unresponsive to treatment for over 5 years.

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My condition didn't improve after two types of depression medication and an additional treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with severe depression that includes psychosis.

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I have a primary psychotic disorder, PTSD, or an eating disorder.

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I do not have any brain-affecting illnesses except for a tic disorder.

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I do not have any health conditions that would make surgery risky for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy of amSTN stimulation on OCD symptoms as measured by YBOCS

Incidence of Adverse events

Secondary study objectives

Association between amSTN activity and cognitive/emotional measures as measured by amplitude of neural activity

Association between amSTN activity and cognitive/emotional measures as measured by cross-frequency coupling of neural activity.

Association between amSTN activity and cognitive/emotional measures as measured by phase

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Therapeutic stimulation, then Sham Control stimulationExperimental Treatment2 Interventions

Subjects randomized to this arm are initially "ON" DBS prior to the open label period for 16 weeks and then "OFF" DBS for the next 16 weeks. This is followed by an open-label stimulation period.

Group II: Therapeutic stimulationExperimental Treatment1 Intervention

All participants will transition to an open label stimulation phase for chronic therapy after the cross-over portion of this trial

Group III: Sham Control stimulation, then Therapeutic stimulationExperimental Treatment2 Interventions

Subject randomized to this arm are initially "OFF" DBS (Deep Brain Stimulation) prior to the open label period for 16 weeks and then "ON" DBS for the next 16 weeks. This is then followed by an open-label period of DBS stimulation.

0 / 7Eligibility criteria met