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

Sponsor

National Yang Ming University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04041661

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Other: Active tDCS plus gait training Other: Sham tDCS plus gait training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Aug 31, 2020

Anticipated Study Completion Date :

Aug 31, 2020

Arms and Interventions

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.	Other: Active tDCS plus gait training 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.	Other: Sham tDCS plus gait training Participants in control group will accept Sham tDCS which combined with treadmill

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.

Other: Active tDCS plus gait training

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.

Other: Sham tDCS plus gait training

Participants in control group will accept Sham tDCS which combined with treadmill

Outcome Measures

Primary Outcome Measures

Dual-task walking performance [Change from baseline at 4 weeks]
To evaluate gait parameters while doing dual-task walking

Secondary Outcome Measures

Single walking performance [Change from baseline at 4 weeks]
To evaluate gait parameters while doing single walking
Trail-making test A & B [Change from baseline at 4 weeks]
To evaluate executive function
Stroop color and word test-Chinese version [Change from baseline at 4 weeks]
To evaluate executive function
Digit span test [Change from baseline at 4 weeks]
To evaluate executive function

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Yang Ming University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yea-Ru Yang, Professor, National Yang Ming University

ClinicalTrials.gov Identifier:

NCT04041661

Other Study ID Numbers:

19MMHIS113e

First Posted:

Aug 1, 2019

Last Update Posted:

Aug 6, 2019

Last Verified:

Aug 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yea-Ru Yang, Professor, National Yang Ming University

Dual task performance

Executive function

Transcrainal direct current stimulation (tDCS)

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Aug 6, 2019