Development of Adaptive Deep Brain Stimulation for OCD

NAActive, not recruitingINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

October 11, 2019

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Obsessive-Compulsive Disorder
Interventions
DEVICE

Summit RC+S System

"Summit RC+S System consists of:~(i) One Model B35300R Olympus RC+S neurostimulator; (ii) One Model 4NR009 Patient Therapy Manager; (iii) One Model 4NR011 Clinician Telemetry Module; (iv) Two Model 3387 DBS leads; (v) Two Model 37087-60 DBS extensions; and (vi) One Model 97755 Recharger."

OTHER

One Month Blinded Discontinuation Period:

"The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform sham activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline."

Trial Locations (3)

15260

University of Pittsburgh, Pittsburgh

77030

Baylor College of Medicine, Houston

02912

Brown University, Providence

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

University of Pittsburgh

OTHER

collaborator

Brown University

OTHER

collaborator

Carnegie Mellon University

OTHER

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Medtronic

INDUSTRY

lead

Baylor College of Medicine

OTHER

NCT04281134 - Development of Adaptive Deep Brain Stimulation for OCD | Biotech Hunter | Biotech Hunter