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

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson's Disease, Tremor, Dystonia

Intervention / Treatment
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* Other: Alteration of DBS stimulator settings


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBS on<br>baseline settings | Other: Alteration of DBS stimulator settings<br>* Alteration of DBS stimulator settings<br>|
| No Intervention: DBS off<br>DBS off | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency | This is the percentage of time the subject is in bed when he/she is actually asleep. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wake after sleep onset (WASO) | This is a measurement of the amount of time during polysomnography recording that the subject is awake after their initial sleep onset. | 1 month | 
| Total Sleep Time |  | 1 month | 
| Two timed motor tasks | 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. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DBS, Parkinson's disease, Tremor, Dystonia, Sleep