The Effect of Different Intensities of Bilateral- and Cathodal-tDCS in Healthy Individuals

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05929014
Collaborator
(none)
20
1
4
8.2
2.4

Study Details

Study Description

Brief Summary

This study will be divided into 2 sub-study 1) To investigate the effects of 1 mA, 1.5 mA, and 2 mA of bilateral- tDCS on cortical activity and motor/cognitive performances in healthy individuals 2) To investigate the effects of 1 mA, 1.5 mA, and 2 mA of cathodal-tDCS on cortical activity and motor/cognitive performances in healthy individuals.

Condition or Disease Intervention/Treatment Phase
  • Device: Bilateral-Transcranial direct current stimulation (bilateral-tDCS)
  • Device: Cathodal-Transcranial direct current stimulation (cathodal-tDCS)
  • Device: Sham bilateral-tDCS
  • Device: Sham cathodal-tDCS
N/A

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 cathodal-tDCS among different doses on cortical excitability and on motor performance are still controversial no report of a non-linear effect for bilateral-tDCS.

The present study will be investigated the effects of different intensities of unilateral cathodal tDCS and bilateral tDCS on cortical activity and functional outcomes in healthy individuals. A single session of different intensities of bilateral-tDCS or 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 will be measured as a primary outcome. All power bands (alpha, beta, delta, theta) will be analyzed. Moreover, analysis of brain activity will be also focused on both hemispheres. The reaction time of serial reaction time task and muscle strength will be served as the secondary outcome. Cortical activity and muscle strength will be evaluated before and after the intervention, while reaction time will be evaluated during and after the intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The participants who will participate in one of two studies will be randomly received 1 mA or 1.5 mA or 2 mA or sham with the washout period for at least 2 weeks. The participants could not participate in both studies.The participants who will participate in one of two studies will be randomly received 1 mA or 1.5 mA or 2 mA or sham with the washout period for at least 2 weeks. The participants could not participate in both studies.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Different Intensities of Bilateral- and Cathodal-transcranial Direct Current Stimulation (tDCS) on Cortical Activity and Motor Performances in Healthy Individuals
Actual Study Start Date :
Jun 24, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

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

    Active Comparator: Active cathodal-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 cathodal montage which applied cathodal electrode over left hemisphere and anodal over right orbit.

    Device: Cathodal-Transcranial direct current stimulation (cathodal-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 electrode will be attached over the left primary motor area while the anodal will be applied over the right supraorbital.
    Other Names:
  • MINDD STIM; Ybrain Inc., Korea
  • Sham Comparator: Sham cathodal-tDCS

    Participants will be received sham of cathodal tDCS during performed serial reaction time task.

    Device: Sham cathodal-tDCS
    Sham cathodal-tDCS

    Outcome Measures

    Primary Outcome Measures

    1. Cortical activity [5 minutes]

      Acquired by electroencephalography (EEG)

    2. The reaction time [30 minutes]

      Measured the reaction time from serial reaction time task

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. Age 18-29 years old
      1. Righ-hand dominant according to the Edinburgh handedness inventory
      1. No injury to both upper and lower limb for the past 6 months
    Exclusion Criteria:
      1. Presence of any neurological disorders
      1. Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers
      1. Presence of opened wound or infectious wound around scalp
      1. History of epilepsy or any neurological antecedent or unstable condition which can lead to seizure
      1. Body mass index (BMI) > 30 kg/m2
      1. Received hormonal treatment and/or drugs that increase sleepiness and affect movement control
      1. Ischemic heart disease and peripheral vascular ischemia
      1. Last stage of kidney disease and liver disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Physical Therapy, Mahidol University Salaya Nakonpathom Thailand 73170

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Wanalee Klomjai, PhD, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT05929014
    Other Study ID Numbers:
    • MU-CIRB 2023/016.1601
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahidol University

    Study Results

    No Results Posted as of Jul 3, 2023