- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04041661
Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease
August 2, 2019 updated by: Yea-Ru Yang, National Yang Ming University
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yearu Yang, Ph.D
- Phone Number: +88628267279
- Email: yryang@ym.edu.tw
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active tDCS plus gait training group
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 experimental group will accept Active tDCS which combined with treadmill
|
Sham Comparator: Sham tDCS plus gait training group
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.
|
Participants in control group will accept Sham tDCS which combined with treadmill
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dual-task walking performance
Time Frame: Change from baseline at 4 weeks
|
To evaluate gait parameters while doing dual-task walking
|
Change from baseline at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single walking performance
Time Frame: Change from baseline at 4 weeks
|
To evaluate gait parameters while doing single walking
|
Change from baseline at 4 weeks
|
Trail-making test A & B
Time Frame: Change from baseline at 4 weeks
|
To evaluate executive function
|
Change from baseline at 4 weeks
|
Stroop color and word test-Chinese version
Time Frame: Change from baseline at 4 weeks
|
To evaluate executive function
|
Change from baseline at 4 weeks
|
Digit span test
Time Frame: Change from baseline at 4 weeks
|
To evaluate executive function
|
Change from baseline at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 1, 2019
Primary Completion (Anticipated)
August 31, 2020
Study Completion (Anticipated)
August 31, 2020
Study Registration Dates
First Submitted
July 31, 2019
First Submitted That Met QC Criteria
July 31, 2019
First Posted (Actual)
August 1, 2019
Study Record Updates
Last Update Posted (Actual)
August 6, 2019
Last Update Submitted That Met QC Criteria
August 2, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19MMHIS113e
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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