HealthyNCT05929014

Effects of Different Intensities of Bilateral- and Cathodal Transcranial Direct Current Stimulation in Healthy Individuals

A study testing study 1) Active bilateral-tDCS and study 2) active cathodal-tDCS in people with Healthy, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will separate study to investigate the effects of 1 mA, 1.5 mA, and 2 mA of 1) bilateral- and 2) cathodal tDCS on cortical activity and motor learning in healthy individuals Read more about this study

Who is it for?: Ages 18 to 29 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: study 1) Active bilateral-tDCS and study 2) active cathodal-tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteThailand
Study dates: 24 Jun 2023to 28 Feb 2025
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 29 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

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

Other trials in Thailand

About this study

Official title: The Effect of Different Intensities of Bilateral- and Cathodal Transcranial Direct Current Stimulation (tDCS) on Cortical Activity and Motor Learning in Healthy Individuals

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

Read the 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 separated into 2 sub studies to investigated the effects of different intensities of 1) bilateral- and 2) cathodal-tDCS on cortical activity and functional outcomes in healthy individuals. A single session of different intensities of 1) bilateral-tDCS and 2) cathodal-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.

Conditions: Healthy
Being tested: study 1) Active bilateral-tDCS, study 1) Sham bilateral-tDCS, study 2) active cathodal-tDCS, study 2) Sham chathodal-tDCS
Keywords: tDCS, Cortical activity, Healthy, Motor learning, Brain symmetry index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

study 1) Active bilateral-tDCSDevice
Also called MINDD STIM; Ybrain Inc., Korea
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.
study 1) Sham bilateral-tDCSDevice
Participants will be received sham mode. The electrodes will be applied over bilateral primary motor areas.
study 2) active cathodal-tDCSDevice
Also called MINDD STIM; Ybrain Inc., Korea
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 left supra orbital area and cahtodal electrodes will be applied over the primary motor areas.
study 2) Sham chathodal-tDCSDevice
Participants will be received sham mode. The anodal electrode will be applied over the left supra orbital area and cathodal electrode will be applied over the right primary motor area.

Study groups in NCT05929014
Study group	Role	What they receive
Study 1) Active bilateral-tDCS	Active comparator	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. Receives: Device: study 1) Active bilateral-tDCS
study 1) Sham bilateral-tDCS	Sham comparator	Participants will be received sham of bilateral tDCS during performed serial reaction time task. Receives: Device: study 1) Sham bilateral-tDCS
study 2) Active cathodal-tDCS	Active comparator	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 cathodal montage which applied anodal electrode over right supra orbital and cathodal electrode over left hemisphere. Receives: Device: study 2) active cathodal-tDCS
study 2) Sham cathodal-tDCS	Sham comparator	Participants will be received sham of cathodal tDCS during performed serial reaction time task. Receives: Device: study 2) Sham chathodal-tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 202328 Feb 2025

First posted3 Jul 2023
Study start24 Jun 2023
Primary completion30 Nov 2023
Study completion28 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: The participants of 2 sub studies (bilateral-tDCS and cathodal-tDCS) who will participate in the study will be randomly received 1 mA or 1.5 mA or 2 mA or sham with the washout period for at least 2 weeks.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05929014
Sponsor's protocol ID: MU-CIRB 2023/016.1601
Status last verified: May 2025
First submitted: 25 Jun 2023
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Prathum T, Dauguet J, Apiworajirawit I, Aneksan B, Hoisan S, Tragangoon A, Siripornpanich V, Klomjai W. Modulation of interhemispheric inhibition and motor learning by different intensities of bilateral transcranial direct current stimulation in healthy adults. Sci Rep. 2025 Dec 22;15(1):45140. doi: 10.1038/s41598-025-33298-8.
PubMed 41429892

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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