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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03486795

Collaborator

(none)

Enrollment

Location

Arms

6.3

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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 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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: M1 stimulation Device: PMC stimulation Device: Sham stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 31, 2017

Actual Primary Completion Date :

May 10, 2018

Actual Study Completion Date :

May 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual stimulation anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex 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 Sham stimulation	Device: Sham stimulation sham stimulation over both primary motor cortex and premotor cortex

Outcome Measures

Primary Outcome Measures

Changes in motor evoked potential [Baseline and after intervention (approximately 30 minutes)]
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle

Secondary Outcome Measures

Changes in sequential motor task [Baseline and after intervention (approximately 30 minutes)]
measures motor functional and dexterity of hand

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT03486795

Other Study ID Numbers:

2017-08-124-C

First Posted:

Apr 3, 2018

Last Update Posted:

Sep 20, 2019

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Samsung Medical Center

transcranial direct current stimulation

motor function

Study Results

No Results Posted as of Sep 20, 2019