NCT03486795

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2017

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

Study Start

First participant enrolled

October 31, 2017

Completed
5 months until next milestone

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
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2018

Completed
Last Updated

September 20, 2019

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

March 22, 2018

Last Update Submit

September 19, 2019

Conditions

Healthy

Keywords

transcranial direct current stimulationmotor function

Outcome Measures

Primary Outcomes (1)

  • Changes in motor evoked potential

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

    Baseline and after intervention (approximately 30 minutes)

Secondary Outcomes (1)

  • Changes in sequential motor task

    Baseline and after intervention (approximately 30 minutes)

Study Arms (4)

Dual stimulation

EXPERIMENTAL

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

M1 stimulation

EXPERIMENTAL

anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex

Device: M1 stimulation

PMC stimulation

EXPERIMENTAL

anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area

Device: PMC stimulation

Sham stimulation

SHAM COMPARATOR

Sham stimulation

Device: Sham stimulation

Interventions

M1 stimulationDEVICE

stimulating primary motor cortex with anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex

Dual stimulationM1 stimulation
PMC stimulationDEVICE

stimulating premotor cortex with anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area

PMC stimulation
Sham stimulationDEVICE

sham stimulation over both primary motor cortex and premotor cortex

Sham stimulation

Eligibility Criteria

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

You may qualify if:

  • healthy subjects with age over 19 years old

You may not qualify if:

  • history of disorders involving central nervous system
  • patients with severe medial or psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

March 22, 2018

First Posted

April 3, 2018

Study Start

October 31, 2017

Primary Completion

May 10, 2018

Study Completion

May 10, 2018

Last Updated

September 20, 2019

Record last verified: 2018-03

Locations

KR(1)