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Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

M1 stimulation

PMC stimulation

aIPS stimulation

hand motor task

About this trial

This is an interventional treatment trial for Stroke focused on measuring transcranial direct current stimulation, dual stimulation

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Dual Stimulation 1

Dual Stimulation 2

Single stimulation

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Changes in motor evoked potentia

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

Secondary Outcome Measures

changes in nine hole peg test

Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.

changes in grip and tip pinch strength test

measure the hand strength (grip and tip pinch)

changes in box and block test

box and block test measures unilateral gross manual dexterity

Changes in brain activation of resting-state functional MRI

Neuroplasticity measure

Changes of Cortical activation

Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany)

Full Information

NCT ID

NCT03486769

First Posted

March 22, 2018

Last Updated

May 25, 2020

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03486769

Brief Title

Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients

Official Title

Effect of Dual Site-dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

May 23, 2018 (Actual)

Primary Completion Date

March 17, 2020 (Actual)

Study Completion Date

March 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

transcranial direct current stimulation, dual stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dual Stimulation 1

Arm Type

Experimental

Arm Description

Arm Title

Dual Stimulation 2

Arm Type

Experimental

Arm Description

Arm Title

Single stimulation

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

M1 stimulation

Other Intervention Name(s)

primary motor cortex anodal stimulation

Intervention Description

stimulating primary motor cortex with anodal transcranial direct current stimulation

Intervention Type

Device

Intervention Name(s)

PMC stimulation

Other Intervention Name(s)

premotor cortex anodal stimulation

Intervention Description

stimulating premotor cortex with anodal transcranial direct current stimulation

Intervention Type

Device

Intervention Name(s)

aIPS stimulation

Intervention Description

stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation

Intervention Type

Behavioral

Intervention Name(s)

hand motor task

Intervention Description

hand motor task for 30 minutes during transcranial direct current stimulation

Primary Outcome Measure Information:

Title

Changes in motor evoked potentia

Description

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

Time Frame

Baseline and after intervention (approximately 2 weeks)

Secondary Outcome Measure Information:

Title

changes in nine hole peg test

Description

Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

changes in grip and tip pinch strength test

Description

measure the hand strength (grip and tip pinch)

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

changes in box and block test

Description

box and block test measures unilateral gross manual dexterity

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

Changes in brain activation of resting-state functional MRI

Description

Neuroplasticity measure

Time Frame

Baseline and after intervention (approximately 2 weeks)

Title

Changes of Cortical activation

Description

Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany)

Time Frame

Baseline and after intervention (approximately 2 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: unilateral hemiplegic stroke patient Fugl Meyer Assessment score between 9 to 84 Exclusion Criteria: difficult to understand experimental tasks because of extremely severe cognitive impairment history of psychiatric disease

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Dual Site-dual Channel Non-invasive Brain Stimulation for Motor Function in Stroke Patients

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