ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease (ParkinStim)

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

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 Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Procedure: Active tDCS; Procedure: Sham tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Great Lakes NeuroTechnologies Inc.
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Rush University Medical Center
• Investigators: Principal Investigator: Dustin A Heldman, Ph.D., Great Lakes NeuroTechnologies

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: April 25, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Parkinson's disease; Transcranial direct current stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 1R43NS077652-01A1 (U.S. NIH Grant/Contract)