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

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

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.

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

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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