HealthyNCT04211779
a-tDCS Combined With Aerobic Exercise in Healthy Individuals
A study testing Real tDCS and Exercise in people with Healthy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Real tDCS and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 29 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject
- No use of any ergogenic substance in one year
- No history of active exercise training in last 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Real tDCS, Sham tDCS, Exercise
- Keywords
- Transcranial Direct Current Stimulation, Aerobic Exercise, Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tDCSDevice
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.
Sham tDCSDevice
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.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS and Exercise | Experimental | 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. Receives: Device: Real tDCS; Other: Exercise |
| Sham tDCS and Exercise | Sham comparator | 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. Receives: Device: Sham tDCS; Other: Exercise |
| Exercise | Other | Exercise group in which will receive the active intervention of aerobic exercise training no tDCS intervention. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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").
Measured: 2 months
Secondary outcomes (1)
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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Mar 2020 (estimated)
- Primary completion29 Oct 2021 (estimated)
- Study completion29 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mine Gülden Polat, PhD, Study director, Marmara UniversityLütfü Hanoğlu, PhD, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211779
- Sponsor's protocol ID
- 09.2019.669
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anodal Transcranial Direct Current Stimulation Combined With Aerobic Exercise on Performance in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04211779
- Acronym / sponsor ID
- 09.2019.669
- Conditions
- Healthy
- Keywords
- Transcranial Direct Current Stimulation, Aerobic Exercise, Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 29 Oct 2021 (estimated)
- Study completion
- 29 Dec 2021 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real tDCS and Exercise | Experimental | Device: Real tDCS, Other: ExercisetDCS (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. |
| Sham tDCS and Exercise | Sham comparator | Device: Sham tDCS, Other: ExerciseSham 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. |
| Exercise | Other | Other: ExerciseExercise group in which will receive the active intervention of aerobic exercise training no tDCS intervention. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subject
- No use of any ergogenic substance in one year
- No history of active exercise training in last 6 months
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real tDCSReal 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. | Device | Real tDCS and Exercise |
| Sham tDCSSham 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. | Device | Sham tDCS and Exercise |
| ExerciseThe Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes. | Other | Exercise, Real tDCS and Exercise, Sham tDCS and Exercise |
Primary outcome
Effect of tDCS combined with aerobic exercise on exercise performance in healthy individuals.
Time frame: 2 months
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
Effect of tDCS combined with aerobic exercise on ratings of perceived exertion (RPE) in healthy individuals.
Time frame: 2 months
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").
1 secondary outcome
Effect of tDCS combined with aerobic exercise on isokinetic muscle strength in healthy individuals.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mine Gülden Polat, PhD study director
Marmara University
Lütfü Hanoğlu, PhD study chair
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real tDCS and Exercise in people with Healthy, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahar Ayberk, MSc (00902164140545, bahar.ayberk@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of tDCS combined with aerobic exercise on exercise performance in healthy individuals. (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.