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

May 25, 2020 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: M1 stimulation
stimulating primary motor cortex with anodal transcranial direct current stimulation
Other Names:
  • primary motor cortex anodal stimulation
Device: PMC stimulation
stimulating premotor cortex with anodal transcranial direct current stimulation
Other Names:
  • premotor cortex anodal stimulation
Behavioral: hand motor task
hand motor task for 30 minutes during transcranial direct current stimulation
EXPERIMENTAL: 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.
Device: M1 stimulation
stimulating primary motor cortex with anodal transcranial direct current stimulation
Other Names:
  • primary motor cortex anodal stimulation
Behavioral: hand motor task
hand motor task for 30 minutes during transcranial direct current stimulation
Device: aIPS stimulation
stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation
EXPERIMENTAL: Single stimulation
anodal stimulation on ipsilesional primary motor cortex and cathodal stimulation on contralesional primary motor cortex
Device: M1 stimulation
stimulating primary motor cortex with anodal transcranial direct current stimulation
Other Names:
  • primary motor cortex anodal stimulation
Behavioral: hand motor task
hand motor task for 30 minutes during transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in motor evoked potentia
Time Frame: Baseline and after intervention (approximately 2 weeks)
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.
Baseline and after intervention (approximately 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Cortical activation
Time Frame: Baseline and after intervention (approximately 2 weeks)
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany)
Baseline and after intervention (approximately 2 weeks)
changes in nine hole peg test
Time Frame: Baseline and after intervention (approximately 2 weeks)
Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.
Baseline and after intervention (approximately 2 weeks)
changes in grip and tip pinch strength test
Time Frame: Baseline and after intervention (approximately 2 weeks)
measure the hand strength (grip and tip pinch)
Baseline and after intervention (approximately 2 weeks)
changes in box and block test
Time Frame: Baseline and after intervention (approximately 2 weeks)
box and block test measures unilateral gross manual dexterity
Baseline and after intervention (approximately 2 weeks)
Changes in brain activation of resting-state functional MRI
Time Frame: Baseline and after intervention (approximately 2 weeks)
Neuroplasticity measure
Baseline and after intervention (approximately 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 23, 2018

Primary Completion (ACTUAL)

March 17, 2020

Study Completion (ACTUAL)

March 17, 2020

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

April 1, 2018

First Posted (ACTUAL)

April 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-08-124-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on M1 stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe