RecruitingNot ApplicableNCT05623306

SEEG-Guided DBS for OCD

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


Sponsor

Katherine Scangos

Enrollment

10 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-site, 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 DBS surgery 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 study is testing a brain stimulation approach called deep brain stimulation (DBS) for people with severe, treatment-resistant obsessive-compulsive disorder (OCD). Before placing the permanent stimulator, researchers first use special brain monitoring (SEEG electrodes) to map the best location to target, with the goal of improving outcomes compared to standard DBS. **You may be eligible if...** - You are between 22 and 75 years old - You have had severe OCD for more than 5 years that significantly disrupts daily life - You have tried at least 2 different SSRI medications at adequate doses, an antipsychotic add-on, clomipramine, and cognitive behavioral therapy, without adequate relief - You live within 6 hours driving distance of the study site and plan to stay in the area for roughly 2 years - You have stable housing and at least two emergency contacts **You may NOT be eligible if...** - You have another primary psychiatric diagnosis such as bipolar disorder, schizophrenia, or an active eating disorder - You have current suicidal risk or a history of a suicide attempt - You have a pacemaker or other implanted electrical or brain device - You have metal in your head (outside the mouth) - You are pregnant or plan to become pregnant during the 3-year study - You have a history of significant head trauma or other serious medical conditions 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.

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Interventions

DEVICEPMT Stereoencephalography (SEEG)

For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.

DEVICEVercise Genus™ Deep Brain Stimulation (DBS) System or Percept™ PC Neurostimulation System

For Stages 2 and 3 of this study, we intend to use the DBS system to treat patients with severe symptoms of chronic, treatment-refractory OCD by targeting stimulation to sites that have been determined to have therapeutic benefit during our SEEG Invasive Monitoring phase.


Locations(2)

Stanford University

Stanford, California, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT05623306


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