10
Participants
Start Date
March 20, 2014
Primary Completion Date
August 25, 2021
Study Completion Date
August 24, 2023
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."
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."
University of Florida, Gainesville
Collaborators (1)
Medtronic
INDUSTRY
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Florida
OTHER