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Completed

NCT Number: NCT03460886

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipsilesional stimulation

Device

anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes

Contralesional stimulation

Device

anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes

Walking on treadmill

Other

walking on treadmill for 10 minutes

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2018
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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