Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders
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|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||Phase|
|Parkinson's Disease Tremor Dystonia||Other: Alteration of DBS stimulator settings||Not Applicable|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|