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

This study is ongoing, but not recruiting participants.
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 12, 2016
Last verified: January 2016
  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: Allocation: Randomized
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:


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.


Enrollment: 17
Study Start Date: July 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBS on
baseline settings
Other: Alteration of DBS stimulator settings
Alteration of DBS stimulator settings
No Intervention: DBS off
DBS off

  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01169324

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Amy W Amara, MD, phD UAB Neurology
  More Information

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 12, 2016
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
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Dyskinesias
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Parkinsonian Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on May 30, 2016