a-tDCS Combined With Aerobic Exercise in Healthy Individuals

The Effect of Anodal Transcranial Direct Current Stimulation Combined With Aerobic Exercise on Performance in Healthy Individuals

The purpose of this study is to assess the effects on the exercise performance of anodal transcranial direct current stimulation combined with aerobic exercise in healthy individuals.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Device: Real tDCS; Other: Exercise; Device: Sham tDCS

Detailed Description

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has become increasingly popular in recent years. tDCS shows promising improvements for the motor performance of healthy individuals as well as pathological conditions. Moreover, it is frequently preferred because of its safety advantage, high tolerability as well as being cheap, portable and easily applicable.

Studies have shown that tDCS can modulate the excitability of both cortical and subcortical brain regions. In recent years, there have been scientific studies investigating the effects of tDCS on improving physical performance in healthy individuals, but these studies are limited in number, their results are conflicted and as far as the investigators know there is no study that combines tDCS with exercise.

Moreover, although the mechanisms of tDCS on physical performance are largely unknown, some tDCS devices are open to public usage and a large number of professional athletes have reported using tDCS during their training programs. Therefore, studies are needed to demonstrate the effects of tDCS which combined with exercise on performance.

The aim of this study was to investigate the effects of anodal transcranial direct current stimulation combined with aerobic exercise on physical performance in healthy individuals.

• Study Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy subject
• No use of any ergogenic substance in one year
• No history of active exercise training in last 6 months

Exclusion Criteria:

• Pacemaker
• Intracerebral metallic implant
• Using dietary supplementation or medication potentially affecting the CNS
• Musculoskeletal injury within the past 6 weeks
• Lower extremity pain above 3 or more according to numeric pain scale
• History of epilepsy or convulsive crisis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real tDCS and Exercise; tDCS (tDCS - TCT Research Limited, Hong Kong) / Exercise Group in which will receive the active intervention of aerobic exercise training and active tDCS intervention at the same time.	Device: Real tDCS; Real tDCS (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The active session of tDCS will consist in applying anodal stimulation over left M1 (C3 according to the 10-20 international EEG placement) and the cathodal stimulation over right supraorbital area (Fp2 according to the 10-20 international EEG placement), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp.; Other: Exercise; The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.
Sham Comparator: Sham tDCS and Exercise; Sham tDCS (tDCS - TCT Research Limited, Hong Kong) / Exercise Group in which will receive the active intervention of aerobic exercise training and sham tDCS intervention at the same time.	Other: Exercise; The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.; Device: Sham tDCS; Sham current (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The sham tDCS will use the same montage and device but direct current will only be injected for 30 seconds, with a ramp-up and ramp-down 15 seconds period, to mimic the somatosensory effects of active tDCS.
Other: Exercise; Exercise group in which will receive the active intervention of aerobic exercise training no tDCS intervention.	Other: Exercise; The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of tDCS combined with aerobic exercise on exercise performance in healthy individuals.	The performance will be evaluated by measuring the maximal consumption of oxygen (VO2max). VO2max will be assessed continuously during the time to exhaustion trial using a gas analyzer	2 months
Effect of tDCS combined with aerobic exercise on ratings of perceived exertion (RPE) in healthy individuals.	RPE will be assessed continuously (every 3 minutes) during the time to exhaustion trial using the Borg rating of perceived exertion scale (RPE scale). The Borg RPE scale is a quantitative measure of perceived exertion during physical activity. The scale starts with "no feeling of exertion," which rates a 6, and ends with "very, very hard," which rates a 20. Moderate activities register 11 to 14 on the Borg scale ("fairly light" to "somewhat hard"), while vigorous activities usually rate a 15 or higher ("hard" to "very, very hard").	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of tDCS combined with aerobic exercise on isokinetic muscle strength in healthy individuals.	The isokinetic muscle strength of knee extensors of the dominant leg will be evaluated by using Biodex System 3 isokinetic dynamometer (Biodex Medical Systems, Shirley, NY, USA)	2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in SF-36 questionnaire of quality of life	This questionnaire evaluates different aspects of individual life such as Vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Through different questions, a score is generated for each subscale where zero represents the worst quality of life and 100 the best quality of life.	2 months
Changes in Cognitive Test Battery	An n-back cognitive test will be conducted for assessing the working memory.	2 months

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: Mine Gulden Polat, PhD, Marmara University; Study Chair: Lutfu Hanoglu, PhD, Medipol University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): October 29, 2021
• Study Completion (Anticipated): December 29, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation; Performance; Aerobic Exercise
• Other Study ID Numbers: 09.2019.669

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
• product manufactured in and exported from the U.S.: No