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

Not Applicable

Completed

• Conditions: Gait Disorders, Neurologic; Stroke
• Interventions: Device: Ipsilesional stimulation; Other: Walking on treadmill; Device: Contralesional stimulation

• Registration Number: NCT03460886
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-22
• Study Start: 2018-02-01
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-09
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ipsilesional stimulation	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.
Ipsilesional stimulation	Walking on treadmill	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.
Bihemispheric stimulation	Walking on treadmill	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.
Sham	Walking on treadmill	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.
Bihemispheric stimulation	Ipsilesional 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.
Bihemispheric stimulation	Contralesional 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.
Contralesional stimulation	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.
Contralesional stimulation	Walking on treadmill	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.

Primary Outcome Measures

Name	Time	Method
Changes in motor evoked potential	before and after intervention (approximately 30 minutes)	measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle.

Secondary Outcome Measures

Name	Time	Method
Changes in 10 meter walking test	before and after intervention (approximately 30 minutes)	measures gait speed
Timed up and go test	before and after intervention (approximately 30 minutes)	measures gait capacity and balance
Functional ambulatory category	before and after intervention (approximately 30 minutes)	measure gait ability. 0 is impossible to gait and 6 is normal.
Changes in Fugl Meyer Assessment	before and after intervention (approximately 30 minutes)	Fugl Meyer Assessment is a measurement of motor function.
Changes in motricity index	before and after intervention (approximately 30 minutes)	measures motor function
Modified ashworth scale	before and after intervention (approximately 30 minutes)	measures spasticity with scale from 0 to 3. 0 is no increase in muscle tone. 3 is considerable increase in muscle tone, passive movement difficult.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of