ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Procedure: Active tDCSProcedure: Sham tDCS
- Registration Number
- NCT02125383
- Lead Sponsor
- Great Lakes NeuroTechnologies Inc.
- Brief Summary
The purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- Clinical diagnosis of idiopathic Parkinson's disease (PD) according to the UK PD brain bank criteria
- Hoehn and Yahr stage II-III when off anti-parkinsonian medication
- Able to provide informed consent
- Currently taking levodopa (300-800 mg per day)
- On stable regimen of anti-parkinsonian medication for at least one month before study entry and able to continue on a stable regimen for the duration of the study
- Presence of early morning akinesia
- Naïve to tDCS.
- Children will be excluded from this study due to the fact that they are unlikely to have PD
- Significant medical or psychiatric illness, significant neurological disease other than PD, metal objects and/or deep brain stimulators in the head that might pose a hazard during tDCS
- Dementia, as evidenced by a score less than 26 on the Montreal Cognitive Assessment
- Significant depression (Geriatric Depression Scale score < 20)
- Presence of hallucinations
- Having undergone any surgical procedure for treatment of PD including deep brain stimulation (DBS), pallidotomy, thalamotomy, or other brain surgeries
- A history of seizures
- A known history of severe sleep apnea or sleep onset insomnia
- Skin diseases that could potentially cause irritations under electrodes
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active tDCS Active tDCS Receives 20 minutes of anodal tDCS three times while sleeping during the night. Sham tDCS Sham tDCS Receives 20 minutes of sham tDCS three times while sleeping during the night.
- Primary Outcome Measures
Name Time Method PD motor scores measured by Kinesia HomeView 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.
- Secondary Outcome Measures
Name Time Method Overnight Polysomnography During each sleep study Polysomnography parameters will be compared during the active and sham tDCS sleep studies.
tDCS sensations 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.
Sleepiness Average change from two days before tDCS sleep study to two days after tDCS sleep study Epworth Sleepiness Scale
Motor scores measured by the Unified Parkinson's Disease Rating Scale Average change from day before tDCS sleep study to day after tDCS sleep study
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States