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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
Great Lakes NeuroTechnologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Transcranial direct current stimulation

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sleepiness
Epworth Sleepiness Scale
tDCS sensations
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
Overnight Polysomnography
Polysomnography parameters will be compared during the active and sham tDCS sleep studies.

Full Information

First Posted
April 25, 2014
Last Updated
March 9, 2015
Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
Rush University Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT02125383
Brief Title
ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease
Acronym
ParkinStim
Official Title
ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease Phase I
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Lakes NeuroTechnologies Inc.
Collaborators
Rush University Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, Transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Receives 20 minutes of anodal tDCS three times while sleeping during the night.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Receives 20 minutes of sham tDCS three times while sleeping during the night.
Intervention Type
Procedure
Intervention Name(s)
Active tDCS
Intervention Description
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
Intervention Name(s)
Sham tDCS
Intervention Description
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 Outcome Measure Information:
Title
PD motor scores measured by Kinesia HomeView
Description
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.
Time Frame
Average change from two days before tDCS sleep study to two days after tDCS sleep study
Secondary Outcome Measure Information:
Title
Sleepiness
Description
Epworth Sleepiness Scale
Time Frame
Average change from two days before tDCS sleep study to two days after tDCS sleep study
Title
tDCS sensations
Description
Each subject will complete a questionnaire regarding sensations they felt during the night the day after each tDCS sleep study.
Time Frame
Day after tDCS sleep studies
Title
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
Title
Overnight Polysomnography
Description
Polysomnography parameters will be compared during the active and sham tDCS sleep studies.
Time Frame
During each sleep study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dustin A Heldman, Ph.D.
Organizational Affiliation
Great Lakes NeuroTechnologies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease

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