The Effect of Low Frequency STN DBS on Sleep and Vigilance in Parkinson's Disease (PD) Patients
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|ClinicalTrials.gov Identifier: NCT01769690|
Recruitment Status : Active, not recruiting
First Posted : January 17, 2013
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Other: DBS stimulator setting alteration Other: virtual reality simulator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Participant was blinded to the DBS settings during the sleep study but investigator was not; however, the investigator was blinded to the DBS setting during the interpretation of the sleep study.|
|Official Title:||The Effect of Low Frequency STN DBS on Sleep and Vigilance in PD Patients|
|Actual Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
|Experimental: DBS stimulator setting alteration||
Other: DBS stimulator setting alteration
Other: virtual reality simulator
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
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
- Differences in sleep efficiency between the high and low frequency nights [ Time Frame: 3 non-consecutive nights of sleep study within 4 weeks ]Phase I subjects will undergo 2 sleep studies, one with the stimulator "on" at the subject's stable, clinically effective settings and one with the stimulator "off." Phase 2 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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769690
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Amy Amara, MD||University of Alabama at Birmingham|