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

This study is currently recruiting participants.
Verified January 2013 by University of Alabama at Birmingham
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Amy Amara, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01769690
First received: January 10, 2013
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Parkinson's Disease
 Other: DBS stimulator setting alteration
Other: virtual reality simulator

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 48
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)
Arms Assigned Interventions
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 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.
Other Name: Wake time vigilance in PD patients

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who have undergone unilateral subthalamic nucleus (STN) DBS surgery for treatment of PD.
  2. Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
  3. Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5)
  4. 19 years of age or older
  5. Ability to walk up and down stairs

Exclusion Criteria:

  1. Known narcolepsy
  2. Other previous surgical treatment of Parkinson's disease(with the exception of unilateral STN DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
  3. Pregnant women will be excluded from this study.
  4. Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with continuous positive airway pressure (CPAP), they can re-start the study.
  5. Inability to walk without assistance, including a cane, wheelchair, or walker
  6. Cognitive dysfunction that would prevent subject's ability to participate in the study.
  7. Blindness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769690

Contacts
Contact: Amy Amara, MD 205-934-0683 amyamara@uab.edu
Contact: Kristin Ford 205-934-0683 kjade@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Amy Amara, MD     205-934-0683     amyamara@uab.edu    
Contact: Kristin Ford     205-934-0683     kjade@uab.edu    
Principal Investigator: Amy Amara, MD            
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Amy Amara, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Amy Amara, MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01769690     History of Changes
Other Study ID Numbers: F121004006, 1K23NS080912
Study First Received: January 10, 2013
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
PD
Parkinson's Disease
DBS
deep brain stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 16, 2013