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

NCT01769690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-06

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Amy Amara, MD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769690 on ClinicalTrials.gov