NCT03486769

Brief Summary

The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in post stroke patients. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through three conditions of transcranial direct current stimulation with for 30 minutes. Three conditions are 1) Dual stimulation 1: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area. 2) Dual stimulation 2: i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area. 3) Single stimulation: anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 23, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

May 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1.8 years

First QC Date

March 22, 2018

Last Update Submit

May 25, 2020

Conditions

Stroke

Keywords

transcranial direct current stimulationdual stimulation

Outcome Measures

Primary Outcomes (1)

  • Changes in motor evoked potentia

    measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.

    Baseline and after intervention (approximately 2 weeks)

Secondary Outcomes (5)

  • changes in nine hole peg test

    Baseline and after intervention (approximately 2 weeks)

  • changes in grip and tip pinch strength test

    Baseline and after intervention (approximately 2 weeks)

  • changes in box and block test

    Baseline and after intervention (approximately 2 weeks)

  • Changes in brain activation of resting-state functional MRI

    Baseline and after intervention (approximately 2 weeks)

  • Changes of Cortical activation

    Baseline and after intervention (approximately 2 weeks)

Study Arms (3)

Dual Stimulation 1

EXPERIMENTAL

i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional premotor cortex and cathodal stimulation on contralesional supraorbital area.

Device: M1 stimulationDevice: PMC stimulationBehavioral: hand motor task

Dual Stimulation 2

EXPERIMENTAL

i) anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex, ii) anodal stimulation on ipsilesional anterior intraparietal sulcus and cathodal stimulation on contralesional supraorbital area.

Device: M1 stimulationDevice: aIPS stimulationBehavioral: hand motor task

Single stimulation

EXPERIMENTAL

anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex

Device: M1 stimulationBehavioral: hand motor task

Interventions

M1 stimulationDEVICE

stimulating primary motor cortex with anodal transcranial direct current stimulation

Also known as: primary motor cortex anodal stimulation
Dual Stimulation 1Dual Stimulation 2Single stimulation
PMC stimulationDEVICE

stimulating premotor cortex with anodal transcranial direct current stimulation

Also known as: premotor cortex anodal stimulation
Dual Stimulation 1
aIPS stimulationDEVICE

stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation

Dual Stimulation 2
hand motor taskBEHAVIORAL

hand motor task for 30 minutes during transcranial direct current stimulation

Dual Stimulation 1Dual Stimulation 2Single stimulation

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral hemiplegic stroke patient
  • Fugl Meyer Assessment score between 9 to 84

You may not qualify if:

  • difficult to understand experimental tasks because of extremely severe cognitive impairment
  • history of psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 3, 2018

Study Start

May 23, 2018

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

May 27, 2020

Record last verified: 2020-03

Locations

KR(1)