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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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