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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT01169324

Collaborator

(none)

Enrollment

Location

Arms

64.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease Tremor Dystonia	Other: Alteration of DBS stimulator settings	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 15, 2010

Actual Primary Completion Date :

Dec 11, 2015

Actual Study Completion Date :

Dec 11, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DBS on baseline settings	Other: Alteration of DBS stimulator settings Alteration of DBS stimulator settings
No Intervention: DBS off DBS off

Arm

Intervention/Treatment

Experimental: DBS on

baseline settings

Other: Alteration of DBS stimulator settings

Alteration of DBS stimulator settings

No Intervention: DBS off

DBS off

Outcome Measures

Primary Outcome Measures

Sleep Efficiency [1 month]
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) [1 month]
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 [1 month]
Two timed motor tasks [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.