search
Back to results

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

Primary Purpose

Healthy

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Bilateral-Transcranial direct current stimulation (bilateral-tDCS)
Cathodal-Transcranial direct current stimulation (cathodal-tDCS)
Sham bilateral-tDCS
Sham cathodal-tDCS
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring tDCS, Cortical activity, Healthy, Motor performance, Cognitive

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Physical Therapy, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Active bilateral-tDCS

Sham bilateral-tDCS

Active cathodal-tDCS

Sham cathodal-tDCS

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 25, 2023
Last Updated
June 30, 2023
Sponsor
Mahidol University
search

1. Study Identification

Unique Protocol Identification Number
NCT05929014
Brief Title
The Effect of Different Intensities of Bilateral- and Cathodal-tDCS in Healthy Individuals
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
tDCS, Cortical activity, Healthy, Motor performance, Cognitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active bilateral-tDCS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham bilateral-tDCS
Arm Type
Sham Comparator
Arm Description
Participants will be received sham of bilateral tDCS during performed serial reaction time task.
Arm Title
Active cathodal-tDCS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham cathodal-tDCS
Arm Type
Sham Comparator
Arm Description
Participants will be received sham of cathodal tDCS during performed serial reaction time task.
Intervention Type
Device
Intervention Name(s)
Bilateral-Transcranial direct current stimulation (bilateral-tDCS)
Other Intervention Name(s)
MINDD STIM; Ybrain Inc., Korea
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cathodal-Transcranial direct current stimulation (cathodal-tDCS)
Other Intervention Name(s)
MINDD STIM; Ybrain Inc., Korea
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham bilateral-tDCS
Intervention Description
Sham bilateral-tDCS
Intervention Type
Device
Intervention Name(s)
Sham cathodal-tDCS
Intervention Description
Sham cathodal-tDCS
Primary Outcome Measure Information:
Title
Cortical activity
Description
Acquired by electroencephalography (EEG)
Time Frame
5 minutes
Title
The reaction time
Description
Measured the reaction time from serial reaction time task
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanalee Klomjai, PhD
Phone
+6624415450
Ext
20216
Email
wanalee.klo@mahidol.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanalee Klomjai, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy, Mahidol University
City
Salaya
State/Province
Nakonpathom
ZIP/Postal Code
73170
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanalee Klomjai, PhD
Phone
+6624415450
Ext
20216
Email
wanalee.klo@mahidol.edu
First Name & Middle Initial & Last Name & Degree
Wanalee Klomjai, PhD
First Name & Middle Initial & Last Name & Degree
Benchaporn Aneksan, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs