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NCT Number: NCT01169324

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Dystonia Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tremor

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alteration of DBS stimulator settings

Other

Alteration of DBS stimulator settings

Primary outcomes

  1. Sleep Efficiency

    Time frame: 1 month

    This is the percentage of time the subject is in bed when he/she is actually asleep.

Secondary outcomes

  1. Wake after sleep onset (WASO)

    Time frame: 1 month

    This is a measurement of the amount of time during polysomnography recording that the subject is awake after their initial sleep onset.

  2. Total Sleep Time

    Time frame: 1 month

  3. Two timed motor tasks

    Time frame: 1 month

    • The subject will tap index finger between 2 points 30 cm apart on the table for 10 seconds.
    • The subject will be timed as they rise from a chair, walk 7 meters, return to the chair, and sit down.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Effect of DBS on Sleep Architecture in Patients With Movement Disorders.

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jul 26, 2010
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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