Responsive Deep Brain Stimulator for Essential Tremor

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 1, 2017

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Essential Tremor
Interventions
DEVICE

Deep brain stimulation

The deep brain stimulation system includes an implantable neurostimulator, thalamic leads to be implanted in the ventral intermediate nucleus (Vim), and subdural cortical strips. The deep brain stimulation 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 deep brain stimulation. At 6 months, the investigators will determine whether or not the subject is a candidate for closed-loop deep brain stimulation. Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. These subjects will been seen every 6 months for evaluation as part of normal clinical care for deep brain stimulation.

DEVICE

Closed-loop deep brain stimulation

The deep brain stimulation system includes an implantable neurostimulator, Vim thalamic leads, and subdural strips. Six months post-surgery, the deep brain stimulation 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 deep brain stimulation. 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)

32611

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