Dual Site-Dual Channel Non-invasive Brain Stimulation for Motor Function in Healthy Subjects

September 19, 2019 updated by: Samsung Medical Center

Effect of Dual Site-Dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Healthy Subjects

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 healthy subjects. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex, ii) anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 2) M1 stimulation: anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex; 3) PMC stimulation: anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 4) sham stimulation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subjects with age over 19 years old

Exclusion Criteria:

  • history of disorders involving central nervous system
  • patients with severe medial or 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: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dual stimulation
  1. anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex
  2. anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area
Device: M1 stimulation
stimulating primary motor cortex with anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex
EXPERIMENTAL: M1 stimulation
anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex
Device: M1 stimulation
stimulating primary motor cortex with anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex
EXPERIMENTAL: PMC stimulation
anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area
Device: PMC stimulation
stimulating premotor cortex with anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area
SHAM_COMPARATOR: Sham stimulation
Device: Sham stimulation
sham stimulation over both primary motor cortex and premotor cortex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in motor evoked potential
Time Frame: Baseline and after intervention (approximately 30 minutes)
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle
Baseline and after intervention (approximately 30 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in sequential motor task
Time Frame: Baseline and after intervention (approximately 30 minutes)
measures motor functional and dexterity of hand
Baseline and after intervention (approximately 30 minutes)

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)

October 31, 2017

Primary Completion (ACTUAL)

May 10, 2018

Study Completion (ACTUAL)

May 10, 2018

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)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-08-124-C

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.

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