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
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
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
NCT ID
NCT04041661
First Posted
July 31, 2019
Last Updated
August 2, 2019
Sponsor
National Yang Ming University
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
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