AthleteNCT03901508
A Single Session of tDCS (Transcranial Direct Current Stimulation) Improves Endurance for 30 Minutes
A study testing TDCS in people with Athlete and Healthy, run by University of Liege at 1 site in Belgium.
Trial summary
Healthy recreational athletes will undergo a session of anodal tDCS (transcranial direct current stimulation) or sham tDCS. The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' strength before and 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
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Apr 2019to 5 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
- Between 3 and 5 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: A Single Session of a-tDCS Improves Lower Limb Endurance for 30 Minutes in Healthy Subjects
Healthy recreational athletes will undergo a session of anodal tDCS (transcranial direct current stimulation) or sham tDCS.
The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' strength before and after each session
Read the detailed description
Healthy recreational athletes will be recruited through social media and advertisements.
Each subject came 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 underwent a concentric and eccentric isokinetic test of their lower limbs (dominant or non-dominant side depending on their group). Subjects then received either anodal tDCS, of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, there was a another isokinetic test, and 30 minutes after the second test, a subjects underwent a third test.
- Being tested
- TDCS
- Keywords
- tDCS, Athlete, Isokinetic, Strength, Endurance
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, 2 electrodes (C3/FP2)
| 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.
Isokinetic Peak Strength
Concentric and Eccentric Peak Strength is measured in hamstrings and quadriceps at 60°/s using an isokinetic dynamometer
Measured: Changes between prior to tDCS, immediately following tDCS and 30 minutes after tDCS
Isokinetic Work
Concentric and Eccentric Work is measured in hamstrings and quadriceps at 60°/s using an isokinetic dynamometer
Measured: Changes between prior to tDCS, immediately following tDCS and 30 minutes after tDCS
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 start5 Apr 2019
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthleteStudies 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
- Parallel groups
- Model description
- Randomized, triple-blind, sham-controlled, crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT03901508
- Sponsor's protocol ID
- 2017/29
- Status last verified
- Mar 2020
- First submitted
- 29 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
- A Single Session of a-tDCS Improves Lower Limb Endurance for 30 Minutes in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03901508
- Acronym / sponsor ID
- 2017/29
- Keywords
- tDCS, Athlete, Isokinetic, Strength, Endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 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.
Healthy recreational athletes will undergo a session of anodal tDCS (transcranial direct current stimulation) or sham tDCS.
The primary outcome is an isokinetic evaluation of their hamstrings' and quadriceps' strength before and after each session
Detailed description
Healthy recreational athletes will be recruited through social media and advertisements.
Each subject came 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 underwent a concentric and eccentric isokinetic test of their lower limbs (dominant or non-dominant side depending on their group). Subjects then received either anodal tDCS, of sham tDCS. Neither the evaluator or the subject knew which they were receiving. Immediately following tDCS, there was a another isokinetic test, and 30 minutes after the second test, a subjects underwent a third test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (2 listed)
- Between 3 and 5 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, 2 electrodes (C3/FP2) | Device | Anodal tDCS, Sham tDCS |
Primary outcome
Isokinetic Peak Strength
Time frame: Changes between prior to tDCS, immediately following tDCS and 30 minutes after tDCS
Concentric and Eccentric Peak Strength is measured in hamstrings and quadriceps at 60°/s using an isokinetic dynamometer
Isokinetic Work
Time frame: Changes between prior to tDCS, immediately following tDCS and 30 minutes after tDCS
Concentric and Eccentric Work is measured in hamstrings and quadriceps at 60°/s using an isokinetic dynamometer
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 Athlete and Healthy, 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?
Isokinetic Peak Strength (time frame: Changes between prior to tDCS, immediately following tDCS and 30 minutes after tDCS). 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 31 Mar 2020.