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Completed

NCT Number: NCT02125383

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active tDCS

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sleepiness

    Time frame: Average change from two days before tDCS sleep study to two days after tDCS sleep study

    Epworth Sleepiness Scale

  2. 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.

  3. 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

  4. Overnight Polysomnography

    Time frame: During each sleep study

    Polysomnography parameters will be compared during the active and sham tDCS sleep studies.

Sponsors and collaborators

Lead sponsor

Great Lakes NeuroTechnologies Inc.

Industry

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Rush University Medical Center

Registry information

Official study title

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

Acronym: ParkinStim

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2014
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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