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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460886
• Other study ID #: 2017-11-080
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: May 30, 2018

Study information

• Verified date: September 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Stroke

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in motor evoked potential	measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle.	before and after intervention (approximately 30 minutes)
Secondary	Changes in motricity index	measures motor function	before and after intervention (approximately 30 minutes)
Secondary	Changes in Fugl Meyer Assessment	Fugl Meyer Assessment is a measurement of motor function.	before and after intervention (approximately 30 minutes)
Secondary	Changes in 10 meter walking test	measures gait speed	before and after intervention (approximately 30 minutes)
Secondary	Timed up and go test	measures gait capacity and balance	before and after intervention (approximately 30 minutes)
Secondary	Functional ambulatory category	measure gait ability. 0 is impossible to gait and 6 is normal.	before and after intervention (approximately 30 minutes)
Secondary	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.	before and after intervention (approximately 30 minutes)