Application of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient

NCT ID: NCT04591236

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-03

Study Completion Date

2021-06-18

Brief Summary

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The purpose of this study was to investigate the effect of simultaneous application of transcranial direct current stimulation (tDCS) and treadmill gait training for gait function recovery in Parkinson's disease patients with gait impairment.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Gait training with brain stimulation

Treadmill gait training and transcranial direct current stimulation (tDCS) on the leg motor areas

Group Type EXPERIMENTAL

Brain stimulation

Intervention Type DEVICE

tDCS brain stimulation on leg motor areas was applied to Parkinson patients.

Treadmill gait training

Intervention Type DEVICE

Treadmill gait training was applied to Parkinson patients.

Gait training with sham brain stimulation

Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas

Group Type ACTIVE_COMPARATOR

Treadmill gait training

Intervention Type DEVICE

Treadmill gait training was applied to Parkinson patients.

Interventions

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Brain stimulation

tDCS brain stimulation on leg motor areas was applied to Parkinson patients.

Intervention Type DEVICE

Treadmill gait training

Treadmill gait training was applied to Parkinson patients.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age: 50 - 75 years
* Modified Hoehn and Yahr stages 1 to 4

Exclusion Criteria

* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
* Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
* History of psychiatric disease
* Implanted objects that would contraindicate tDCS
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yun-Hee Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yun-Hee Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2020-09-093

Identifier Type: -

Identifier Source: org_study_id

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