Deep Brain Stimulation for Obsessive-Compulsive Disorder

Recruiting at1 trial location

Overseen by Darin Dougherty, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a device that sends electrical signals to the brain to help patients with severe OCD who haven't responded to other treatments. It works by correcting abnormal brain activity and also records data to help researchers understand the treatment better. Deep brain stimulation (DBS) is an innovative treatment for severe obsessive-compulsive disorder (OCD).

Research Team

Darin Dougherty, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults aged 21-65 with severe OCD, not improved after multiple treatments including drugs and behavioral therapy, can join this trial. They must be in good health, understand the study, consent to it, have a supportive family member or friend, and live near the study site. Excluded are those with psychotic disorders, low IQ/cognitive impairments affecting consent ability, bipolar disorder history, MRI contraindications like metal implants or claustrophobia.

Inclusion Criteria

I am in good health overall.

Patient is aware of, able to adhere to, and willing to tolerate the frequency of visits associated with adjustment of the dual-stimulation configuration and/or collection of brain recordings. This will usually mean limitation to patients who live close to the study site

Platelet count greater than 125,000 per cubic millimeter and a PT and PTT within normal limits

Exclusion Criteria

Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WAIS) or cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably, as determined by the consent monitor and the site psychiatrist

I am not pregnant and if of childbearing age, I use effective contraception.

Imminent risk of suicide or an inability to control suicide attempts (in the investigators' judgment)

Treatment Details

Interventions

• Medtronic PC+S Deep Brain Stimulation (Deep Brain Stimulation)
• Medtronic Percept Deep Brain Stimulation (Deep Brain Stimulation)

Trial Overview The Medtronic PC+S deep brain stimulation device is being tested as a treatment for patients with intractable OCD. This involves surgical implantation of electrodes into specific brain areas to modulate activity through electrical impulses.

Participant Groups

Group I: Medtronic Percept Deep Brain Stimulation Experimental Treatment 1 Intervention

Single open label arm. Patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) will receive stimulation in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with a novel Medtronic Percept deep brain stimulation (DBS) system.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School