Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke

NCT ID: NCT03460886

Last Updated: 2019-09-20

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

2018-02-01

Study Completion Date

2018-05-30

Brief Summary

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The aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation - anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area. 4) sham stimulation. Subjects will walk on treadmill for 10 minutes during transcranial direct current stimulation. Motor evoked potential and functional evaluations will be done before and after stimulation to measure the changes.

Detailed Description

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Conditions

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Stroke Gait Disorders, Neurologic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bihemispheric stimulation

1. Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area
2. Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation.

Group Type EXPERIMENTAL

Ipsilesional stimulation

Intervention Type DEVICE

anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes

Contralesional stimulation

Intervention Type DEVICE

anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes

Walking on treadmill

Intervention Type OTHER

walking on treadmill for 10 minutes

Ipsilesional stimulation

1. Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area
2. Sham on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation.

Group Type EXPERIMENTAL

Ipsilesional stimulation

Intervention Type DEVICE

anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes

Walking on treadmill

Intervention Type OTHER

walking on treadmill for 10 minutes

Contralesional stimulation

1. Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area
2. Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation.

Group Type EXPERIMENTAL

Contralesional stimulation

Intervention Type DEVICE

anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes

Walking on treadmill

Intervention Type OTHER

walking on treadmill for 10 minutes

Sham

1. Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area
2. Sham stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation.

Group Type ACTIVE_COMPARATOR

Walking on treadmill

Intervention Type OTHER

walking on treadmill for 10 minutes

Interventions

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Ipsilesional stimulation

anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes

Intervention Type DEVICE

Contralesional stimulation

anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes

Intervention Type DEVICE

Walking on treadmill

walking on treadmill for 10 minutes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chronic stroke patients with 6 months after onset.
* Functional ambulation category ≥ 3

Exclusion Criteria

* patients who needs assist in surface level walking
* patients with mini mental status exam score under 9
* patients with implantable electronic device
* metal device inside skull
* history of epilepsy
* pregnancy
Minimum Eligible Age

20 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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Responsibility Role SPONSOR

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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2017-11-080

Identifier Type: -

Identifier Source: org_study_id

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