Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders
|ClinicalTrials.gov Identifier: NCT01169324|
Recruitment Status : Active, not recruiting
First Posted : July 26, 2010
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment|
|Parkinson's Disease Tremor Dystonia||Other: Alteration of DBS stimulator settings|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of DBS on Sleep Architecture in Patients With Movement Disorders.|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: DBS on
Other: Alteration of DBS stimulator settings
Alteration of DBS stimulator settings
No Intervention: DBS off
- Sleep Efficiency [ Time Frame: 1 month ]This is the percentage of time the subject is in bed when he/she is actually asleep.
- 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.
- Total Sleep Time [ Time Frame: 1 month ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169324
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Amy W Amara, MD, phD||UAB Neurology|