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

Primary Purpose

Parkinson's Disease, Tremor, Dystonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alteration of DBS stimulator settings
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson's Disease focused on measuring Parkinson's disease, Tremor, Dystonia, DBS, Sleep

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DBS on

DBS off

Arm Description

baseline settings

DBS off

Outcomes

Primary Outcome Measures

Sleep Efficiency
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)
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
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.

Full Information

First Posted
July 2, 2010
Last Updated
April 25, 2019
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01169324
Brief Title
Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders
Official Title
Effect of DBS on Sleep Architecture in Patients With Movement Disorders.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 15, 2010 (Actual)
Primary Completion Date
December 11, 2015 (Actual)
Study Completion Date
December 11, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Tremor, Dystonia
Keywords
Parkinson's disease, Tremor, Dystonia, DBS, Sleep

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBS on
Arm Type
Experimental
Arm Description
baseline settings
Arm Title
DBS off
Arm Type
No Intervention
Arm Description
DBS off
Intervention Type
Other
Intervention Name(s)
Alteration of DBS stimulator settings
Intervention Description
Alteration of DBS stimulator settings
Primary Outcome Measure Information:
Title
Sleep Efficiency
Description
This is the percentage of time the subject is in bed when he/she is actually asleep.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Wake after sleep onset (WASO)
Description
This is a measurement of the amount of time during polysomnography recording that the subject is awake after their initial sleep onset.
Time Frame
1 month
Title
Total Sleep Time
Time Frame
1 month
Title
Two timed motor tasks
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy W Amara, MD, phD
Organizational Affiliation
UAB Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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

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