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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460886
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stroke Gait Disorders, Neurologic Device: Ipsilesional stimulation Device: Contralesional stimulation Other: Walking on treadmill Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Walking Problems

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in motricity index [ Time Frame: before and after intervention (approximately 30 minutes) ]
    measures motor function

  2. Changes in Fugl Meyer Assessment [ Time Frame: before and after intervention (approximately 30 minutes) ]
    Fugl Meyer Assessment is a measurement of motor function.

  3. Changes in 10 meter walking test [ Time Frame: before and after intervention (approximately 30 minutes) ]
    measures gait speed

  4. Timed up and go test [ Time Frame: before and after intervention (approximately 30 minutes) ]
    measures gait capacity and balance

  5. Functional ambulatory category [ Time Frame: before and after intervention (approximately 30 minutes) ]
    measure gait ability. 0 is impossible to gait and 6 is normal.

  6. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460886


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03460886     History of Changes
Other Study ID Numbers: 2017-11-080
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Medical Center:
transcranial direct current stimulation
Additional relevant MeSH terms:
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Gait Disorders, Neurologic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms