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Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders

This study is currently recruiting participants.
Verified January 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
Amy Amara, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01169324
First received: July 2, 2010
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after the procedure. The cause of this improvement in sleep quality is unknown, and this study proposes the use of polysomnography (PSG) to test whether the improvement in sleep is independent of improvement in night-time mobility associated with DBS treatment of the motor symptoms of PD, tremor, or dystonia.


Condition Intervention
Parkinson's Disease
Tremor
Dystonia
 Other: Alteration of DBS stimulator settings

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of DBS on Sleep Architecture in Patients With Movement Disorders.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Sleep Efficiency [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This is the percentage of time the subject is in bed when he/she is actually asleep.


Secondary Outcome Measures:
  • Wake after sleep onset (WASO) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    This is a measurement of the amount of time during polysomnography recording that the subject is awake after their initial sleep onset.

  • Total Sleep Time [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Two timed motor tasks [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    1. The subject will tap index finger between 2 points 30 cm apart on the table for 10 seconds.
    2. The subject will be timed as they rise from a chair, walk 7 meters, return to the chair, and sit down.


Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBS
Subjects who have undergone DBS for movement disorders
 Other: Alteration of DBS stimulator settings
Alteration of DBS stimulator settings

  Eligibility

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

Inclusion Criteria:

  • Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.
  • Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
  • Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5) at the subject's baseline pre-surgical evaluation.

Exclusion Criteria:

  • Known narcolepsy
  • Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
  • 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 CPAP, they can re-start the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169324

Contacts
Contact: Amy W Amara, MD, PhD 205 934-3411 ext 8014 amyamara@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Amy W Amara, MD, PhD         amyamara@uab.edu    
Sponsors and Collaborators
University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Amy Amara, MD, Instructor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01169324     History of Changes
Other Study ID Numbers: F100528004
Study First Received: July 2, 2010
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Parkinson's disease
Tremor
Dystonia
DBS
Sleep

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Movement Disorders
Parkinson Disease
Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 21, 2013