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

Primary Purpose

Stroke, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ipsilesional stimulation
Contralesional stimulation
Walking on treadmill
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring transcranial direct current stimulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Bihemispheric stimulation

Ipsilesional stimulation

Contralesional stimulation

Sham

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Changes in motor evoked potential
measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle.

Secondary Outcome Measures

Changes in motricity index
measures motor function
Changes in Fugl Meyer Assessment
Fugl Meyer Assessment is a measurement of motor function.
Changes in 10 meter walking test
measures gait speed
Timed up and go test
measures gait capacity and balance
Functional ambulatory category
measure gait ability. 0 is impossible to gait and 6 is normal.
Modified ashworth scale
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.

Full Information

First Posted
January 22, 2018
Last Updated
September 19, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03460886
Brief Title
Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke
Official Title
Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait Disorders, Neurologic
Keywords
transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bihemispheric stimulation
Arm Type
Experimental
Arm Description
Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation.
Arm Title
Ipsilesional stimulation
Arm Type
Experimental
Arm Description
Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area Sham on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation.
Arm Title
Contralesional stimulation
Arm Type
Experimental
Arm Description
Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation.
Arm Title
Sham
Arm Type
Active Comparator
Arm Description
Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area Sham stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation.
Intervention Type
Device
Intervention Name(s)
Ipsilesional stimulation
Intervention Description
anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes
Intervention Type
Device
Intervention Name(s)
Contralesional stimulation
Intervention Description
anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes
Intervention Type
Other
Intervention Name(s)
Walking on treadmill
Intervention Description
walking on treadmill for 10 minutes
Primary Outcome Measure Information:
Title
Changes in motor evoked potential
Description
measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle.
Time Frame
before and after intervention (approximately 30 minutes)
Secondary Outcome Measure Information:
Title
Changes in motricity index
Description
measures motor function
Time Frame
before and after intervention (approximately 30 minutes)
Title
Changes in Fugl Meyer Assessment
Description
Fugl Meyer Assessment is a measurement of motor function.
Time Frame
before and after intervention (approximately 30 minutes)
Title
Changes in 10 meter walking test
Description
measures gait speed
Time Frame
before and after intervention (approximately 30 minutes)
Title
Timed up and go test
Description
measures gait capacity and balance
Time Frame
before and after intervention (approximately 30 minutes)
Title
Functional ambulatory category
Description
measure gait ability. 0 is impossible to gait and 6 is normal.
Time Frame
before and after intervention (approximately 30 minutes)
Title
Modified ashworth scale
Description
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.
Time Frame
before and after intervention (approximately 30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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