RecruitingNot ApplicableNCT06347978

Personalized DBS for OCD Guided by Stereoencephalography Mapping

A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Four-Lead Personalized Deep Brain Stimulation for Treatment-Refractory Obsessive Compulsive Disorder (SEEG-Guided DBS for OCD)

Sponsor

Andrew Moses Lee, MD, PhD

Enrollment

10 participants

Start Date

May 24, 2024

Study Type

INTERVENTIONAL

Conditions

Obsessive-Compulsive Disorder OCD

Summary

This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.

Eligibility

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a highly personalized form of deep brain stimulation (DBS) — a procedure where a small device is implanted in the brain to send electrical signals — for people with severe, treatment-resistant OCD. Before the implant, doctors use detailed brain mapping (SEEG) to find each patient's unique brain targets. **You may be eligible if...** - You are between 22 and 75 years old - You have had OCD for more than 5 years - Your OCD is severe, causing more than 1 hour of distress per day, and significantly impacts your daily life - You have tried and failed multiple standard OCD treatments, including medications and therapy **You may NOT be eligible if...** - You have another primary psychiatric condition that better explains your symptoms - You have active substance use disorder - You are not medically suitable for brain surgery - You have a significant cognitive impairment or dementia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEDeep Brain Stimulation

Subjects will be randomized to either ON-OFF (Stimulation-Sham) or OFF-ON (Sham-Stimulation) arms. Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period. Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point. After completion of the first phase of the trial, patients will undergo another washout phase until they are within 20% of their pre-treatment Y-BOCS II score or 4 weeks have passed, whichever comes first. The purpose of the washout is to eliminate any residual effect of stimulation in the ON group. Patients will then be advanced to the crossover phase. The participants who were initially randomized to the ON-OFF arm will be moved onto the sham (OFF) period, and the participants who were initially randomized to the OFF-ON group will be moved onto stimulation (ON) period for up to 12 weeks.