Tourette Syndrome Deep Brain Stimulation

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 20, 2014

Primary Completion Date

August 25, 2021

Study Completion Date

August 24, 2023

Conditions
Tourette Syndrome
Interventions
DEVICE

Continuous DBS

"The DBS system includes an implantable neurostimulator, CM thalamic leads, and Electrocorticography (ECOG) strips.~The DBS system will be set to provide continuous stimulation for the 6 months following surgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for DBS. At 6 months, the investigators will determine whether or not the subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study. These subjects will been seen every 6 months for evaluation as part of normal clinical care for DBS."

DEVICE

Responsive Brain Stimulation (RBS Setting)

"The DBS system includes an implantable neurostimulator, CM thalamic leads, and Electrocorticography (ECOG) strips.~Six months post-surgery, the DBS system will be set to provide responsive stimulation for the duration of the study. Subjects will be seen every 6 months for evaluation as a part of normal clinical care for DBS.~Data gathered from the subject during the first 6 months will be used to determine if this intervention is applicable for each individual subject. Subjects who do not qualify will continue to receive the other study intervention."

Trial Locations (1)

32607

University of Florida, Gainesville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

University of Florida

OTHER

NCT02056873 - Tourette Syndrome Deep Brain Stimulation | Biotech Hunter | Biotech Hunter