Effects of Different Intensities of Bilateral-transcranial Direct Current Stimulation in Healthy Individuals

May 28, 2025 updated by: Mahidol University

The Effect of Different Intensities of Bilateral-transcranial Direct Current Stimulation (tDCS) on Cortical Activity and Motor Learning in Healthy Individuals

This study will investigate the effects of 1 mA, 1.5 mA, and 2 mA of bilateral- tDCS on cortical activity and motor learning in healthy individuals

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transcranial direct current stimulation (tDCS) is one of the non-invasive brain stimulation (NIBS) techniques. It delivers weak direct current through the scalp via two electrodes. tDCS has been shown to modulate cortical excitability in polarity-specific effects; anodal increases cortical excitability, while cathodal decreases it. tDCS can be applied in two distinct montages: unilateral (an active electrode is applied over the cerebral cortex, while a reference electrode is applied over the contralateral orbit) and bilateral-tDCS (applying two electrodes simultaneously over both cerebral hemispheres). Many tDCS studies have been used as an add-on therapy in stroke patients which aimed to enhance motor re-learning after stroke. Anodal tDCS has been used to enhance cortical excitability in the lesioned hemisphere while cathodal tDCS is used to decrease it in the non-lesioned hemisphere and thus to rebalance the interhemispheric inhibition (IHI). However, there were recent studies reporting the reverse effect of cathodal-tDCS on cortical excitability at high doses. However, the effects of bilateral-tDCS among different doses on cortical excitability and on motor performance are still controversial.

The present study will be investigated the effects of different intensities of bilateral-tDCS on cortical activity and functional outcomes in healthy individuals. A single session of different intensities of bilateral-tDCS (i.e., 1 mA, 1.5 mA, 2 mA vs. sham) will be combined with serial reaction time task (SRTT) in healthy individuals. Cortical activity (i.e., brain symmetry index (BSI)) will be measured as a primary outcome. The reaction time of serial reaction time task will be served as the secondary outcome. Cortical activity will be evaluated before and after the intervention, while reaction time will be evaluated before, during, and after the intervention.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Thailand
    • Nakonpathom
      • Salaya, Nakonpathom, Thailand, 73170
        • Faculty of Physical Therapy, Mahidol University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. Age 18-29 years old
  • 2. Righ-hand dominant according to the Edinburgh handedness inventory
  • 3. No injury to both upper and lower limb for the past 6 months

Exclusion Criteria:

  • 1. Presence of any neurological disorders
  • 2. Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers
  • 3. Presence of opened wound or infectious wound around scalp
  • 4. History of epilepsy or any neurological antecedent or unstable condition which can lead to seizure
  • 5. Body mass index (BMI) > 30 kg/m2
  • 6. Received hormonal treatment and/or drugs that increase sleepiness and affect movement control
  • 7. Ischemic heart disease and peripheral vascular ischemia
  • 8. Last stage of kidney disease and liver 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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active bilateral-tDCS
Participants will be received different intensities which are 1 mA, 1.5 mA and 2 mA for 20 minutes during performed serial reaction time task. The tDCS will be set with bilateral montage which applied anodal electrode over left hemisphere and cathodal electrode over right hemisphere.
Device: Bilateral-Transcranial direct current stimulation (bilateral-tDCS)
The tDCS is non-invasive brain stimulation technique applied over the participant's scalp using a reference to the International 10-20 electrode Placement System for EEG electrode placement. The cathodal and anodal electrodes will be applied over the right and left primary motor areas, respectively.
Other Names:
  • MINDD STIM; Ybrain Inc., Korea
Sham Comparator: Sham bilateral-tDCS
Participants will be received sham of bilateral tDCS during performed serial reaction time task.
Device: Sham bilateral-tDCS
Sham bilateral-tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical activity
Time Frame: 5 minutes
Acquired by electroencephalography (EEG)
5 minutes
The reaction time
Time Frame: 30 minutes
Measured the reaction time from serial reaction time task
30 minutes

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Wanalee Klomjai, PhD, Mahidol University

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)

June 24, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

June 25, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MU-CIRB 2023/016.1601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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