search
Back to results

Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active tDCS plus gait training
Sham tDCS plus gait training
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Dual task performance, Executive function, Transcrainal direct current stimulation (tDCS)

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with idiopathic PD
  • Hoehn and Yahr stages I-III
  • Mini Mental Status Examination (MMSE) score ≧ 24
  • Could walk 10m independently with or without gait aid

Exclusion Criteria:

  • Concurrent medication likely to affect mental performance
  • tDCS contraindication
  • Significant neurological, vestibular, visual disorders or psychiatric illness
  • Musculoskeletal or cardiopulmonary disease
  • Sensory system pathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Active tDCS plus gait training group

    Sham tDCS plus gait training group

    Arm Description

    Participants in Active tDCS plus gait training group will execute Active tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks.

    Participants in Sham tDCS plus gait training group will executeSham tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks.

    Outcomes

    Primary Outcome Measures

    Dual-task walking performance
    To evaluate gait parameters while doing dual-task walking

    Secondary Outcome Measures

    Single walking performance
    To evaluate gait parameters while doing single walking
    Trail-making test A & B
    To evaluate executive function
    Stroop color and word test-Chinese version
    To evaluate executive function
    Digit span test
    To evaluate executive function

    Full Information

    First Posted
    July 31, 2019
    Last Updated
    August 2, 2019
    Sponsor
    National Yang Ming University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04041661
    Brief Title
    Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease
    Official Title
    The Effect of Concurrent Transcranial Direct Current Stimulation and Gait Training on Gait Performance When Doing the Cognitive Dual-task in People With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2019 (Anticipated)
    Primary Completion Date
    August 31, 2020 (Anticipated)
    Study Completion Date
    August 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Yang Ming University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with Parkinson's Disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Dual task performance, Executive function, Transcrainal direct current stimulation (tDCS)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active tDCS plus gait training group
    Arm Type
    Experimental
    Arm Description
    Participants in Active tDCS plus gait training group will execute Active tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks.
    Arm Title
    Sham tDCS plus gait training group
    Arm Type
    Sham Comparator
    Arm Description
    Participants in Sham tDCS plus gait training group will executeSham tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Active tDCS plus gait training
    Intervention Description
    Participants in experimental group will accept Active tDCS which combined with treadmill
    Intervention Type
    Other
    Intervention Name(s)
    Sham tDCS plus gait training
    Intervention Description
    Participants in control group will accept Sham tDCS which combined with treadmill
    Primary Outcome Measure Information:
    Title
    Dual-task walking performance
    Description
    To evaluate gait parameters while doing dual-task walking
    Time Frame
    Change from baseline at 4 weeks
    Secondary Outcome Measure Information:
    Title
    Single walking performance
    Description
    To evaluate gait parameters while doing single walking
    Time Frame
    Change from baseline at 4 weeks
    Title
    Trail-making test A & B
    Description
    To evaluate executive function
    Time Frame
    Change from baseline at 4 weeks
    Title
    Stroop color and word test-Chinese version
    Description
    To evaluate executive function
    Time Frame
    Change from baseline at 4 weeks
    Title
    Digit span test
    Description
    To evaluate executive function
    Time Frame
    Change from baseline at 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with idiopathic PD Hoehn and Yahr stages I-III Mini Mental Status Examination (MMSE) score ≧ 24 Could walk 10m independently with or without gait aid Exclusion Criteria: Concurrent medication likely to affect mental performance tDCS contraindication Significant neurological, vestibular, visual disorders or psychiatric illness Musculoskeletal or cardiopulmonary disease Sensory system pathology
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yearu Yang, Ph.D
    Phone
    +88628267279
    Email
    yryang@ym.edu.tw

    12. IPD Sharing Statement

    Learn more about this trial

    Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease

    We'll reach out to this number within 24 hrs