ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-02-28

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.

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active tDCS

Receives 20 minutes of anodal tDCS three times while sleeping during the night.

Group Type EXPERIMENTAL

Active tDCS

Intervention Type PROCEDURE

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 tDCS

Receives 20 minutes of sham tDCS three times while sleeping during the night.

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No