ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease
The purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Epworth Sleepiness Scale
- tDCS sensations [ Time Frame: Day after tDCS sleep studies ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
- Overnight Polysomnography [ Time Frame: During each sleep study ] [ Designated as safety issue: No ]Polysomnography parameters will be compared during the active and sham tDCS sleep studies.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
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
The clinical study will follow a counterbalanced crossover design during which subjects will undergo two separate pairs of two-consecutive-overnight sleep studies and receive anodal tDCS (active or sham) to M1. The first sleep study in each pair will acclimate subjects to the sleep laboratory and minimize "first night" effects, thus no tDCS will be applied. The second sleep study in each pair will include active or sham tDCS, presented in a pseudorandom order such that approximately half of the subjects receive active tDCS first while the other half receives sham first. The two pairs of sleep studies will be separated by one to three weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02125383
|United States, Illinois|
|Rush University Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Lucia Blasucci, RN 312-563-2184 Lucia_Blasucci@rush.edu|
|Principal Investigator: Cynthia Comella, M.D.|
|Principal Investigator:||Dustin A Heldman, Ph.D.||Great Lakes NeuroTechnologies|