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

September 19, 2019 updated by: Samsung Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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 Locations

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Ipsilesional stimulation
anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes
Device: Contralesional stimulation
anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes
Other: Walking on treadmill
walking on treadmill for 10 minutes
Experimental: 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.
Device: Ipsilesional stimulation
anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes
Other: Walking on treadmill
walking on treadmill for 10 minutes
Experimental: 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.
Device: Contralesional stimulation
anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes
Other: Walking on treadmill
walking on treadmill for 10 minutes
Active Comparator: 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.
Other: Walking on treadmill
walking on treadmill for 10 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in motor evoked potential
Time Frame: before and after intervention (approximately 30 minutes)
measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle.
before and after intervention (approximately 30 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in motricity index
Time Frame: before and after intervention (approximately 30 minutes)
measures motor function
before and after intervention (approximately 30 minutes)
Changes in Fugl Meyer Assessment
Time Frame: before and after intervention (approximately 30 minutes)
Fugl Meyer Assessment is a measurement of motor function.
before and after intervention (approximately 30 minutes)
Changes in 10 meter walking test
Time Frame: before and after intervention (approximately 30 minutes)
measures gait speed
before and after intervention (approximately 30 minutes)
Timed up and go test
Time Frame: before and after intervention (approximately 30 minutes)
measures gait capacity and balance
before and after intervention (approximately 30 minutes)
Functional ambulatory category
Time Frame: before and after intervention (approximately 30 minutes)
measure gait ability. 0 is impossible to gait and 6 is normal.
before and after intervention (approximately 30 minutes)
Modified ashworth scale
Time Frame: 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.
before and after intervention (approximately 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

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 (Actual)

February 1, 2018

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-11-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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