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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05929014
• Other study ID #: MU-CIRB 2023/016.1601
• Status: Completed
• Phase: N/A
• Start date: June 24, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.
• Sham bilateral-tDCS
Sham bilateral-tDCS
• Sham cathodal-tDCS
Sham cathodal-tDCS

Locations

Country	Name	City	State
Thailand	Faculty of Physical Therapy, Mahidol University	Salaya	Nakonpathom

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical activity	Acquired by electroencephalography (EEG)	5 minutes
Primary	The reaction time	Measured the reaction time from serial reaction time task	30 minutes