HealthyNCT03901222
3D Analysis of the Effects of tDCS (Transcranial Direct Current Stimulation) on a Functional Task in High Level Athletes
A study testing tDCS in people with Healthy and Athlete, run by University of Liege at 1 site in Belgium.
Trial summary
Relatively high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of bi-anodal tDCS (transcranial direct current stimulation) or sham tDCS The primary outcome is a 3D evaluation coupled with EMG (Electromyography) of their primary lower limb muscles after each session Read more about this study
- Who is it for?
- Ages 18 to 35 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
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2019to 31 Aug 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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: 3D Analysis of the Effects of tDCS on a Functional Task in High Level Athletes
Relatively high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of bi-anodal tDCS (transcranial direct current stimulation) or sham tDCS The primary outcome is a 3D evaluation coupled with EMG (Electromyography) of their primary lower limb muscles after each session
Read the detailed description
Recruitment :
Relatively high level athletes will be recruited through social media and advertisements.
Each subject came twice to the Liege University Hospitals' Human Movement Analysis Laboratory.
After placing the different infrared emitters and placing and calibrating the surface EMG electrodes, subjects underwent 3 maximal squat jumps (without upper limb implication). They were then familiarized with the fatigue protocol (8 jumps at a 33 jumps per minute pace).
Then each subject received either bi-anodal tDCS of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, subjects underwent another warmup 3 maximal squat jumps, and then the fatigue protocol (comprised of 30 maximal jumps at a rate of 33 per minute).
- Being tested
- tDCS
- Keywords
- tDCS, Athlete, Endurance, Fatigue, 3D
- 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 \& C4/FPZ) 2mA or sham
| Study group | Role | What they receive |
|---|---|---|
| Bi-Anodal tDCS | Active comparator | Subjects will receive 20 min of bi-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 Height
Peak height (measured by the 3D device) is measured after each of the 30 repetitions as well as after the 3 jumps before and after tDCS. Height decrease will also be looked at
Measured: Changes between Prior and Immediately Following tDCS and Sham
Gluteal EMG (Electromyography) recordings (% of maximal EMG value)
Bilateral Gluteal EMG
Measured: Changes between Prior and Immediately Following tDCS and Sham
Quadriceps EMG (Electromyography) recordings (% of maximal EMG value)
Bilateral Quadriceps EMG triceps surae will be measured
Measured: Changes between Prior and Immediately Following tDCS and Sham
Triceps EMG (Electromyography) recordings (% of maximal EMG value)
Bilateral Triceps Surae EMG
Measured: Changes between Prior and Immediately Following 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 posted3 Apr 2019
- Study start31 Mar 2019
- Primary completion31 Jul 2019
- Study completion31 Aug 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
- 10 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
- NCT03901222
- Sponsor's protocol ID
- 2017/309
- Status last verified
- Mar 2020
- First submitted
- 28 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
- 3D Analysis of the Effects of tDCS on a Functional Task in High Level Athletes
- ClinicalTrials.gov ID
- NCT03901222
- Acronym / sponsor ID
- 2017/309
- Keywords
- tDCS, Athlete, Endurance, Fatigue, 3D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 31 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 3 Apr 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.
Relatively high level athletes will undergo 2 randomized, cross-over counterbalanced sessions of bi-anodal tDCS (transcranial direct current stimulation) or sham tDCS The primary outcome is a 3D evaluation coupled with EMG (Electromyography) of their primary lower limb muscles after each session
Detailed description
Recruitment :
Relatively high level athletes will be recruited through social media and advertisements.
Each subject came twice to the Liege University Hospitals' Human Movement Analysis Laboratory.
After placing the different infrared emitters and placing and calibrating the surface EMG electrodes, subjects underwent 3 maximal squat jumps (without upper limb implication). They were then familiarized with the fatigue protocol (8 jumps at a 33 jumps per minute pace).
Then each subject received either bi-anodal tDCS of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, subjects underwent another warmup 3 maximal squat jumps, and then the fatigue protocol (comprised of 30 maximal jumps at a rate of 33 per minute).
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 |
|---|---|---|
| Bi-Anodal tDCS | Active comparator | Device: tDCSSubjects will receive 20 min of bi-anodal tDCS |
| Sham tDCS | Sham comparator | Device: tDCSSubjects will receive 20 minutes of Sham anodal tDCS |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 \& C4/FPZ) 2mA or sham | Device | Bi-Anodal tDCS, Sham tDCS |
Primary outcome
Peak Height
Time frame: Changes between Prior and Immediately Following tDCS and Sham
Peak height (measured by the 3D device) is measured after each of the 30 repetitions as well as after the 3 jumps before and after tDCS. Height decrease will also be looked at
Gluteal EMG (Electromyography) recordings (% of maximal EMG value)
Time frame: Changes between Prior and Immediately Following tDCS and Sham
Bilateral Gluteal EMG
Quadriceps EMG (Electromyography) recordings (% of maximal EMG value)
Time frame: Changes between Prior and Immediately Following tDCS and Sham
Bilateral Quadriceps EMG triceps surae will be measured
Triceps EMG (Electromyography) recordings (% of maximal EMG value)
Time frame: Changes between Prior and Immediately Following tDCS and Sham
Bilateral Triceps Surae EMG
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 2 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 Height (time frame: Changes between Prior and Immediately Following tDCS and Sham). The study lists 4 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 31 Mar 2020.