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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03460886
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 6.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Gait Disorders, Neurologic	Device: Ipsilesional stimulation; Device: Contralesional stimulation; Other: Walking on treadmill	N/A

Study Design

• Study Type: Interventional
• 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: Feb 1, 2018
• Actual Primary Completion Date: May 30, 2018
• Actual Study Completion Date: May 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bihemispheric stimulation 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.	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 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.	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 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.	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 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.	Other: Walking on treadmill; walking on treadmill for 10 minutes

Outcome Measures

Primary Outcome Measures

1. Changes in motor evoked potential [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 [before and after intervention (approximately 30 minutes)]

   measures motor function

2. Changes in Fugl Meyer Assessment [before and after intervention (approximately 30 minutes)]

   Fugl Meyer Assessment is a measurement of motor function.

3. Changes in 10 meter walking test [before and after intervention (approximately 30 minutes)]

   measures gait speed

4. Timed up and go test [before and after intervention (approximately 30 minutes)]

   measures gait capacity and balance

5. Functional ambulatory category [before and after intervention (approximately 30 minutes)]

   measure gait ability. 0 is impossible to gait and 6 is normal.

6. Modified ashworth scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03460886
• Other Study ID Numbers: 2017-11-080
• First Posted: Mar 9, 2018
• Last Update Posted: Sep 20, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Nervous System Diseases; Gait Disorders, Neurologic

Study Results

No Results Posted as of Sep 20, 2019