The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

February 29, 2020

Study Completion Date

February 29, 2020

Conditions
Parkinson's Disease
Interventions
OTHER

DBS stimulator setting alteration

"2 sleep study options Phase I: Participants will undergo 2 sleep studies, one with the stimulator on at the subject's stable, clinically effective settings and one with the stimulator off. the order of the off and on nights will be randomized. Although blinding will be attempted, because of the significant motor effects produced with the on setting, participants may be able to tell when the DBS is OFF. In the second phase, the first sleep study night will be with the stimulator OFF. The order of the HIGH, and LOW frequency nights will be randomized 1:1 and balanced across subjects and will occur on the 2nd and 3rd PSG nights.~Phase II Sleep study evaluation will include three nights of recording: 1) OFF with the stimulator off, 2) HIGH with the stimulator on at the participant's stable and clinically effective settings, and 3) LOW with the stimulator set at a low frequency that uses less energy"

OTHER

virtual reality simulator

"This virtual pedestrian environment is a measure of real-world street-crossing behavior. This simulation is composed of an elevated platform that simulates a curb at a street-side and 3 monitors (arranged in a semi-circle) on which the subject, while wearing headtracker equipment, views the virtual environment of bidirectional traffic. When the subject deems it is safe to cross the virtual street, he/she steps off the platform/curb, which activates crossing of the street by a cartoon representation of the participant. The speed of street crossing by the cartoon is determined by each individual subject's walking speed, which is measured prior to the test."

Trial Locations (1)

35294

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

University of Alabama at Birmingham

OTHER

NCT01769690 - The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients | Biotech Hunter | Biotech Hunter