ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Great Lakes NeuroTechnologies Inc.
Sponsor:
Collaborators:
Rush University Medical Center
Information provided by (Responsible Party):
Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier:
NCT02125383
First received: April 25, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

The purpose of this study is to evaluate the effects of transcranial direct current stimulation (tDCS) on patients with Parkinson's disease during sleep.


Condition Intervention
Parkinson's Disease
Procedure: Active tDCS
Procedure: Sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I

Resource links provided by NLM:


Further study details as provided by Great Lakes NeuroTechnologies Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Sleepiness [ Time Frame: Average change from two days before tDCS sleep study to two days after tDCS sleep study ] [ Designated as safety issue: No ]
    Epworth Sleepiness Scale

  • tDCS sensations [ Time Frame: Day after tDCS sleep studies ] [ Designated as safety issue: Yes ]
    Each subject will complete a questionnaire regarding sensations they felt during the night the day after each tDCS sleep study.

  • 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 ] [ Designated as safety issue: No ]
  • Overnight Polysomnography [ Time Frame: During each sleep study ] [ Designated as safety issue: No ]
    Polysomnography parameters will be compared during the active and sham tDCS sleep studies.


Estimated Enrollment: 7
Study Start Date: April 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02125383

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Lucia Blasucci, RN    312-563-2184    Lucia_Blasucci@rush.edu   
Principal Investigator: Cynthia Comella, M.D.         
Sponsors and Collaborators
Great Lakes NeuroTechnologies Inc.
Rush University Medical Center
Investigators
Principal Investigator: Dustin A Heldman, Ph.D. Great Lakes NeuroTechnologies
  More Information

No publications provided

Responsible Party: Great Lakes NeuroTechnologies Inc.
ClinicalTrials.gov Identifier: NCT02125383     History of Changes
Other Study ID Numbers: 1R43NS077652-01A1, 1R43NS077652-01A1
Study First Received: April 25, 2014
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Great Lakes NeuroTechnologies Inc.:
Parkinson's disease
Transcranial direct current stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 21, 2014