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

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Samsung Medical Center

Status

Completed

Conditions

Stroke
Gait Disorders, Neurologic

Treatments

Device: Ipsilesional stimulation
Other: Walking on treadmill
Device: Contralesional stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03460886
2017-11-080

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

20+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

24 participants in 4 patient groups

Bihemispheric stimulation
Experimental group
Description:
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.
Treatment:
Other: Walking on treadmill
Device: Contralesional stimulation
Device: Ipsilesional stimulation
Ipsilesional stimulation
Experimental group
Description:
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.
Treatment:
Other: Walking on treadmill
Device: Ipsilesional stimulation
Contralesional stimulation
Experimental group
Description:
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.
Treatment:
Other: Walking on treadmill
Device: Contralesional stimulation
Sham
Active Comparator group
Description:
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.
Treatment:
Other: Walking on treadmill

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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