The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients
The study design is a within-subject randomized cross-over design to evaluate the effects of DBS on sleep architecture, as measured by polysomnography, and on wake-time vigilance, as measured by a virtual reality street-crossing simulator.
Other: DBS stimulator setting alteration
Other: virtual reality simulator
|Study Design:||Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||The Effect of Low Frequency STN DBS on Sleep and Vigilance in PD Patients|
- Differences in sleep efficiency between the high and low frequency nights [ Time Frame: 3 non-consecutive nights of sleep study within 4 weeks ] [ Designated as safety issue: No ]Subjects will spend the first night in the sleep lab with DBS turned off. The order of the high and low frequency nights (on the second and third study nights) will be randomized.
- Wake-time vigilance as measured by a virtual reality street-crossing simulator [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]On the morning following the high and low frequency sleep study nights, subjects will evaluated with a virtual reality street-crossing simulator as a measurement of vigilance.
- Motor outcomes [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Following each sleep study night, subjects will be evaluated with the Unified Parkinson's Disease Rating Scale part III at their overnight DBS settings and 30 minutes after resuming their conventional, motor effective wake-time settings.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
|Experimental: DBS stimulator setting alteration||
Other: DBS stimulator setting alteration
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 energyOther: 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.
Other Name: Wake time vigilance in PD patients
In the proposed study, we will use a within-subject randomized clinical trial to measure objective changes in sleep architecture with DBS "on" and to compare effects of different DBS stimulation parameters on sleep architecture as measured by sleep studies. The study design will allow us to address our hypothesis that low frequency deep brain stimulation parameters are more effective than the conventional settings at improving sleep architecture and wake-time vigilance. If our hypothesis is correct, low frequency settings could be used during sleep and this would prolong stimulator battery life, therefore decreasing the frequency of required surgical battery changes for DBS. These data will be valuable in considering clinical treatment strategies and provide insight into the basic mechanisms of sleep dysfunction in PD. The study may also contribute to understanding how to achieve maximum clinical benefit from DBS while minimizing morbidity and cost.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769690
|Contact: Amy Amara, MDfirstname.lastname@example.org|
|Contact: PK Ellistonemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Amy Amara, MD 205-934-0683 firstname.lastname@example.org|
|Contact: PK Elliston 205-934-0683 email@example.com|
|Principal Investigator: Amy Amara, MD|
|Principal Investigator:||Amy Amara, MD||University of Alabama at Birmingham|