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

Not Applicable

Completed

• Conditions: Parkinson's Disease; Tremor; Dystonia
• Interventions: Other: Alteration of DBS stimulator settings

• Registration Number: NCT01169324
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-02
• Study Start: 2010-07-15
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Primary Completion: 2015-12-11
• Study Completion: 2015-12-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DBS on	Alteration of DBS stimulator settings	baseline settings

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency	1 month	This is the percentage of time the subject is in bed when he/she is actually asleep.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States