HealthyNCT03893604
Effects of tDCS on High Level and Recreational Athletes
A study testing tDCS in people with Healthy and Athlete, run by University of Liege at 1 site in Belgium.
Trial summary
Healthy recreational and high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of anodal tDCS or sham tDCS. The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' endurance after each session Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2019to 30 Jun 2019
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For the "recreational" group at most 3 hours of sport a week
- For the "athletic" group, at least 10 hours of sport a week
- Right handed and footed
Who cannot join
- One on the TSST (in high and relatively high risk sections)
- Previous neurological or orthopedic pathologies affecting limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of tDCS on Endurance Parameters Between High Level and Recreational Athletes
Healthy recreational and high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of anodal tDCS or sham tDCS.
The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' endurance after each session
Read the detailed description
Recruitment :
Healthy recreational and high level athletes will be recruited through social media and advertisements.
Each subject came twice to the Liege University Hospitals' isokinetic lab. Each session began with strapping the subjet into the isokinetic machine, making sure that all the settings were adapted to the subject. Then, each subject received either anodal tDCS, of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, there was a warmup consisting of stationary bike, and an isokinetic warmup. Then, subjects' endurance was using a maximal isokinetic tests, at 30 maximal concentric and eccentric contractions at a speed of 180°/s.
- Being tested
- tDCS
- Keywords
- tDCS, Athlete, Isokinetic, Endurance, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Non invasive brain stimulation
20 minutes of anodal tDCS (C3/FP2) 2mA or sham
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Subjects will receive 20min anodal tDCS Receives: Device: tDCS |
| Sham tDCS | Sham comparator | Subjects will receive 20 minutes of Sham anodal tDCS Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Strength
Peak strength (measured by the isokinetic machine) is measured after each of the 30 repetitions.
Peak strength of the 30 repetitions will be measured, and how strength decreases throughout the test will be analysed
Measured: Immediately after tDCS and sham
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start31 Mar 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, triple-blind, sham-controlled, crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bornheim Stephen, University of Liege
- Investigators
- Stephen Bornheim, Msc, Principal investigator, Liege University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893604
- Sponsor's protocol ID
- 2017-313
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2019
- Last updated
- 31 Mar 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 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of tDCS on Endurance Parameters Between High Level and Recreational Athletes
- ClinicalTrials.gov ID
- NCT03893604
- Acronym / sponsor ID
- 2017-313
- Keywords
- tDCS, Athlete, Isokinetic, Endurance, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 28 Mar 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.
Healthy recreational and high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of anodal tDCS or sham tDCS.
The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' endurance after each session
Detailed description
Recruitment :
Healthy recreational and high level athletes will be recruited through social media and advertisements.
Each subject came twice to the Liege University Hospitals' isokinetic lab. Each session began with strapping the subjet into the isokinetic machine, making sure that all the settings were adapted to the subject. Then, each subject received either anodal tDCS, of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, there was a warmup consisting of stationary bike, and an isokinetic warmup. Then, subjects' endurance was using a maximal isokinetic tests, at 30 maximal concentric and eccentric contractions at a speed of 180°/s.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, triple-blind, sham-controlled, crossover
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: tDCSSubjects will receive 20min anodal tDCS |
| Sham tDCS | Sham comparator | Device: tDCSSubjects will receive 20 minutes of Sham anodal tDCS |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- For the "recreational" group at most 3 hours of sport a week
- For the "athletic" group, at least 10 hours of sport a week
- Right handed and footed
Key exclusion criteria (2 listed)
- One on the TSST (in high and relatively high risk sections)
- Previous neurological or orthopedic pathologies affecting limbs
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 |
|---|---|---|
| tDCSAlso: Non invasive brain stimulation20 minutes of anodal tDCS (C3/FP2) 2mA or sham | Device | Anodal tDCS, Sham tDCS |
Primary outcome
Peak Strength
Time frame: Immediately after tDCS and sham
Peak strength (measured by the isokinetic machine) is measured after each of the 30 repetitions. Peak strength of the 30 repetitions will be measured, and how strength decreases throughout the test will be analysed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
Stephen Bornheim, Msc principal investigator
Liege University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Healthy and Athlete, run by University of Liege at 1 site in Belgium.
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 2 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: finished, as of the sponsor's last update on 31 Mar 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Strength (time frame: Immediately after tDCS and sham). 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 31 Mar 2020.