OCD Biomarker Survey Employing sEEG and Stimulation: The OBSESS Trial — OBSESS  

Obsessive-Compulsive Disorder (OCD) Clinical Trial

Official title: OCD Biomarker Survey Employing sEEG and Stimulation: The OBSESS Trial

Status Not yet recruiting

Clinical Trial Summary

Obsessive-compulsive disorder (OCD) has a lifetime prevalence of 2-3% and is a major cause of global disability. Deep brain stimulation (DBS) is an effective treatment for patients with severe, treatment-resistant forms, but access to and utilization of this therapy remains minimal despite FDA approval via HDE. The investigator's goal is to determine the neurophysiological basis of key symptom domains underlying OCD and derive individual-specific stimulation parameters to improve consistency of outcomes and facilitate outpatient therapy delivery. To do so, the investigators take advantage of key novel DBS device features, including imaging-based "inverse solutions" to determine optimal stimulation parameters, as well as on-device neural recordings that will guide therapy delivery. The investigators will recruit patients with OCD meeting established criteria for surgical evaluation. Each will be implanted with permanent DBS leads and temporary stereo-EEG (sEEG) electrodes. In the inpatient unit, the investigators will first demonstrate how these DBS leads anatomically engage these hub-like DBS target regions and physiologically affect pre-frontal networks. In the outpatient phase, the investigators implement the inverse solutions parameters in a double-blinded head-to-head trial to test whether these personalized parameter sets can reduce symptoms in the domain-specific manner in which the personalized parameters were designed. Doing so would be the first demonstration of data-derived, individual specific DBS programming. Demonstrating clinical outcomes comparable to those achieved by expert programmers but with software-generated stimulation parameters will help demystify the programming process and increase accessibility to this therapy. Finally, and critically, patients will provide chronic on-device recordings labeled with behavioral data from wearables and portables. These naturalistic data will transform the investigator's understanding of the physiological signatures of OCD and provide biomarkers of symptom severity, therapeutic response, and potentially side effects, which will guide future therapy.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Disorder (OCD)

• NCT number: NCT05422469
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Sameer Sheth, MD, PhD
• Phone: 713-798-5060
• Email: sameer.sheth@bcm.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Completion date: January 2029