ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Procedure: Active tDCS
* Procedure: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>Receives 20 minutes of anodal tDCS three times while sleeping during the night. | Procedure: Active tDCS<br>* 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<br>|
| Sham Comparator: Sham tDCS<br>Receives 20 minutes of sham tDCS three times while sleeping during the night. | Procedure: Sham tDCS<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD motor scores measured by Kinesia HomeView | 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. | Average change from two days before tDCS sleep study to two days after tDCS sleep study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleepiness | Epworth Sleepiness Scale | Average change from two days before tDCS sleep study to two days after tDCS sleep study | 
| tDCS sensations | Each subject will complete a questionnaire regarding sensations they felt during the night the day after each tDCS sleep study. | Day after tDCS sleep studies | 
| 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 | 
| Overnight Polysomnography | Polysomnography parameters will be compared during the active and sham tDCS sleep studies. | During each sleep study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Transcranial direct current stimulation