Novel 16-contact Boston Scientific leads (total 64 implanted DBS contacts) for Obsessive Compulsive Disorder (OCD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brown University, Providence, RI
Obsessive Compulsive Disorder (OCD)+1 More
Novel 16-contact Boston Scientific leads (total 64 implanted DBS contacts) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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. The investigators will also use Boston Scientific Illumina software to produce imaging-derived inverse solutions to determine the similarity between intracranial electrophysiology-based solutions vs. imaging-based solutions. Demonstrating clinical outcomes comparable to those achieved by expert programmers but with software-generated (i.e., Illumina-derived) 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.

Eligible Conditions

  • Obsessive Compulsive Disorder (OCD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Obsessive Compulsive Disorder (OCD)

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Through study completion, an average of 14 months

Month 14
Change in Hamilton Depression Inventory (HAM-D) Score
Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score

Trial Safety

Safety Progress

1 of 3

Other trials for Obsessive Compulsive Disorder (OCD)

Trial Design

2 Treatment Groups

Boston Scientific Deep Brain Stimulator
1 of 2
Boston Scientific Deep Brain Stimulator System
1 of 2
Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Novel 16-contact Boston Scientific leads (total 64 implanted DBS contacts) · No Placebo Group · N/A

Boston Scientific Deep Brain Stimulator
Device
Experimental Group · 1 Intervention: Commercially available 8-contact Boston Scientific leads · Intervention Types: Device
Boston Scientific Deep Brain Stimulator System
Device
Experimental Group · 1 Intervention: Novel 16-contact Boston Scientific leads (total 64 implanted DBS contacts) · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 14 months

Trial Background

Prof. Sameer Sheth, Associate Professor
Principal Investigator
Baylor College of Medicine
Closest Location: Brown University · Providence, RI
2004First Recorded Clinical Trial
3 TrialsResearching Obsessive Compulsive Disorder (OCD)
77 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum score of 28 on the Y-BOCS.
You have failed an adequate trial of clomipramine.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.