NCT03460886

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

January 22, 2018

Last Update Submit

September 19, 2019

Conditions

StrokeGait Disorders, Neurologic

Keywords

transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Changes in motricity index

    before and after intervention (approximately 30 minutes)

  • Changes in Fugl Meyer Assessment

    before and after intervention (approximately 30 minutes)

  • Changes in 10 meter walking test

    before and after intervention (approximately 30 minutes)

  • Timed up and go test

    before and after intervention (approximately 30 minutes)

  • Functional ambulatory category

    before and after intervention (approximately 30 minutes)

  • +1 more secondary outcomes

Study Arms (4)

Bihemispheric stimulation

EXPERIMENTAL

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 stimulationDevice: Contralesional stimulationOther: Walking on treadmill

Ipsilesional stimulation

EXPERIMENTAL

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 stimulationOther: Walking on treadmill

Contralesional stimulation

EXPERIMENTAL

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 stimulationOther: Walking on treadmill

Sham

ACTIVE COMPARATOR

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

Interventions

Ipsilesional stimulationDEVICE

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

Bihemispheric stimulationIpsilesional stimulation
Contralesional stimulationDEVICE

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

Bihemispheric stimulationContralesional stimulation
Walking on treadmillOTHER

walking on treadmill for 10 minutes

Bihemispheric stimulationContralesional stimulationIpsilesional stimulationSham

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic stroke patients with 6 months after onset.
  • Functional ambulation category ≥ 3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

March 9, 2018

Study Start

February 1, 2018

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)