ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease (ParkinStim)
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|ClinicalTrials.gov Identifier: NCT02125383|
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : March 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Procedure: Active tDCS Procedure: Sham tDCS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Active tDCS
Receives 20 minutes of anodal tDCS three times while sleeping during the night.
Procedure: Active tDCS
Anodal tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
Sham Comparator: Sham tDCS
Receives 20 minutes of sham tDCS three times while sleeping during the night.
Procedure: Sham tDCS
Sham tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
- PD motor scores measured by Kinesia HomeView [ Time Frame: Average change from two days before tDCS sleep study to two days after tDCS sleep study ]PD motor symptoms will be assessed for two days before (baseline) and two days after each tDCS sleep study using Kinesia HomeView. Changes for active tDCS will be compared to changes for sham tDCS.
- Sleepiness [ Time Frame: Average change from two days before tDCS sleep study to two days after tDCS sleep study ]Epworth Sleepiness Scale
- tDCS sensations [ Time Frame: Day after tDCS sleep studies ]Each subject will complete a questionnaire regarding sensations they felt during the night the day after each tDCS sleep study.
- Motor scores measured by the Unified Parkinson's Disease Rating Scale [ Time Frame: Average change from day before tDCS sleep study to day after tDCS sleep study ]
- Overnight Polysomnography [ Time Frame: During each sleep study ]Polysomnography parameters will be compared during the active and sham tDCS sleep studies.
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): NCT02125383
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Dustin A Heldman, Ph.D.||Great Lakes NeuroTechnologies|