Athletic PerformancePhase 1/2NCT04005846
tDCS to Increase Aerobic Performance in Runners
A Phase 1/2 study testing Transcranial Direct Current Stimulation (tDCS) in people with Athletic Performance, run by University of Liege at 1 site in Belgium.
Trial summary
Many different factors affect running performance, transcranial direct current stimulation (tDCS) is a widely used and available neuromodulation tool and could hypothetically facilitate the supraspinal drive and thereby act upstream of the motor cortex to prolong the muscles work in time to exhaustion trials. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 15 Apr 2023
- Phase
- Phase 1/2
- 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
- Healthy subject
- Regular running activity above 2 hours/week
- VO2max above 30 mL/min/kg
Who cannot join
- Pacemaker
- Intracerebral metallic implant
- Smoking
- Using dietary supplementation or medication potentially affecting the CNS
- Musculoskeletal injury within the past 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) to Improve Maximal Aerobic Performance in Recreational and Trained Runners
Many different factors affect running performance, transcranial direct current stimulation (tDCS) is a widely used and available neuromodulation tool and could hypothetically facilitate the supraspinal drive and thereby act upstream of the motor cortex to prolong the muscles work in time to exhaustion trials. While it appears to decrease the rating of perceived exertion (RPE) during cycling, little is known about the effects of tDCS on physiological performance parameters such as maximal oxygen consumption (VO2max), maximal aerobic speed (MAS) and lactate thresholds in runners.
The aim of this prospective randomized sham-controlled clinical trial is to investigate the physiological effects of tDCS applied over the motor cortex on perceived exertion and performance-related parameters measured by an incremental treadmill test to exhaustion.
Read more
This research thus aims at answering the following questions:
- Is active tDCS applied bilaterally over the motor cortex significantly more efficient than sham tDCS to improve the TTE?
- Does active tDCS decreases the RPE, as compared to sham?
- Is there any significant difference between active and sham tDCS on the physiological parameters measured during an incremental test to exhaustion, namely: VO2max, MAS, respiratory exchange ratio, blood lactate levels, maximal heart rate?
- Does the baseline level of physical fitness influences response to tDCS?
The investigators hypothesize that 1) performance as measured by time to exertion will be increased following active and not sham tDCS due to a decreased perceived rate of exertion without significantly altering the other physiological parameters; and 2) performance as measured by incremental treadmill test to exhaustion will be more improved in recreational as compared to trained runners.
- Conditions
- Athletic Performance
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
The active session of tDCS will consist in applying two anodes over M1 bilaterally (C3 and C4 according to the 10-20 international EEG placement) and the cathodes over the occipital areas (O1 and O2), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp using the Startsim 8 (Neuroelectrics, Barcelona). 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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS first / Sham tDCS second | Other | Receiving active tDCS during the first visit followed by sham tDCS on the next visit Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS first / Active tDCS second | Other | Receiving sham tDCS during the first visit followed by active tDCS on the next visit Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to exertion (active vs. sham)
Time to achieve exhaustion during a treadmill test where the speed is set at a constant 90% of the individual maximal aerobic speed (determined during the screening visit)
Measured: Immediate
Secondary outcomes (3)
Ratings of perceived exertion (RPE) evolution (active vs. sham)
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: Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)
Maximal Oxygen Consumption (VO2max) evolution (active vs. sham)
VO2max will be assessed continuously during the time to exhaustion trial using a gas analyzer
Measured: Immediate
Lactate thresholds (active vs. sham)
Levels of blood lactate will be measured continuously (every 3 minutes) during the time to exhaustion trial using capillary blood and a lactate analyzer
Measured: Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start1 Sep 2019
- Primary completion15 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Athletic PerformanceStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind randomized sham controlled crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Géraldine Martens, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005846
- Sponsor's protocol ID
- CE2019/186
- Status last verified
- May 2023
- First submitted
- 21 Jun 2019
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martens G, Hody S, Bornheim S, Angius L, De Beaumont L, Fregni F, Ruffini G, Kaux JF, Thibaut A, Bury T. Can transcranial direct current stimulation (tDCS) over the motor cortex increase endurance running performance? a randomized crossover-controlled trial. PLoS One. 2024 Dec 5;19(12):e0312084. doi: 10.1371/journal.pone.0312084. eCollection 2024.
PubMed 39637186
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) to Improve Maximal Aerobic Performance in Recreational and Trained Runners
- ClinicalTrials.gov ID
- NCT04005846
- Acronym / sponsor ID
- CE2019/186
- Conditions
- Athletic Performance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 2 Jul 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.
Many different factors affect running performance, transcranial direct current stimulation (tDCS) is a widely used and available neuromodulation tool and could hypothetically facilitate the supraspinal drive and thereby act upstream of the motor cortex to prolong the muscles work in time to exhaustion trials. While it appears to decrease the rating of perceived exertion (RPE) during cycling, little is known about the effects of tDCS on physiological performance parameters such as maximal oxygen consumption (VO2max), maximal aerobic speed (MAS) and lactate thresholds in runners.
The aim of this prospective randomized sham-controlled clinical trial is to investigate the physiological effects of tDCS applied over the motor cortex on perceived exertion and performance-related parameters measured by an incremental treadmill test to exhaustion.
This research thus aims at answering the following questions:
- Is active tDCS applied bilaterally over the motor cortex significantly more efficient than sham tDCS to improve the TTE?
- Does active tDCS decreases the RPE, as compared to sham?
- Is there any significant difference between active and sham tDCS on the physiological parameters measured during an incremental test to exhaustion, namely: VO2max, MAS, respiratory exchange ratio, blood lactate levels, maximal heart rate?
- Does the baseline level of physical fitness influences response to tDCS?
The investigators hypothesize that 1) performance as measured by time to exertion will be increased following active and not sham tDCS due to a decreased perceived rate of exertion without significantly altering the other physiological parameters; and 2) performance as measured by incremental treadmill test to exhaustion will be more improved in recreational as compared to trained runners.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized sham controlled crossover
| Arm | Type | Receives |
|---|---|---|
| Active tDCS first / Sham tDCS second | Other | Device: Transcranial Direct Current Stimulation (tDCS)Receiving active tDCS during the first visit followed by sham tDCS on the next visit |
| Sham tDCS first / Active tDCS second | Other | Device: Transcranial Direct Current Stimulation (tDCS)Receiving sham tDCS during the first visit followed by active tDCS on the next visit |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subject
- Regular running activity above 2 hours/week
- VO2max above 30 mL/min/kg
Key exclusion criteria (5 listed)
- Pacemaker
- Intracerebral metallic implant
- Smoking
- Using dietary supplementation or medication potentially affecting the CNS
- Musculoskeletal injury within the past 6 weeks
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)The active session of tDCS will consist in applying two anodes over M1 bilaterally (C3 and C4 according to the 10-20 international EEG placement) and the cathodes over the occipital areas (O1 and O2), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp using the Startsim 8 (Neuroelectrics, Barcelona). 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 | Active tDCS first / Sham tDCS second, Sham tDCS first / Active tDCS second |
Primary outcome
Time to exertion (active vs. sham)
Time frame: Immediate
Time to achieve exhaustion during a treadmill test where the speed is set at a constant 90% of the individual maximal aerobic speed (determined during the screening visit)
3 secondary outcomes
Ratings of perceived exertion (RPE) evolution (active vs. sham)
Time frame: Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)
Maximal Oxygen Consumption (VO2max) evolution (active vs. sham)
Time frame: Immediate
Lactate thresholds (active vs. sham)
Time frame: Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)
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 9 May 2023.
- Derived from this study: PubMed 39637186Martens G, Hody S, Bornheim S, Angius L, De Beaumont L, Fregni F, Ruffini G, Kaux JF, Thibaut A, Bury T. Can transcranial direct current stimulation (tDCS) over the motor cortex increase endurance running performance? a randomized crossover-controlled trial. PLoS One. 2024 Dec 5;19(12):e0312084. doi: 10.1371/journal.pone.0312084. eCollection 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial Direct Current Stimulation (tDCS) in people with Athletic Performance, 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 5 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 9 May 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to exertion (active vs. sham) (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04005846, which also lists 1 linked publication.
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 9 May 2023.