- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04005846
tDCS to Increase Aerobic Performance in Runners
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Géraldine Martens
- Phone Number: 0032474665261
- Email: geraldine.martens@uliege.be
Study Contact Backup
- Name: Thierry Bury
- Phone Number: 003243663890
- Email: tbury@uliege.be
Study Locations
-
-
-
Liège, Belgium, 4000
- ISEPK ULiège
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy subject
- Regular running activity above 2 hours/week
- VO2max above 30 mL/min/kg
Exclusion Criteria:
- Pacemaker
- Intracerebral metallic implant
- Smoking
- Using dietary supplementation or medication potentially affecting the CNS
- Musculoskeletal injury within the past 6 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Active tDCS first / Sham tDCS second
Receiving active tDCS during the first visit followed by sham tDCS on the next visit
|
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.
|
Other: Sham tDCS first / Active tDCS second
Receiving sham tDCS during the first visit followed by active tDCS on the next visit
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Immediate
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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").
|
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
|
VO2max will be assessed continuously during the time to exhaustion trial using a gas analyzer
|
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)
|
Levels of blood lactate will be measured continuously (every 3 minutes) during the time to exhaustion trial using capillary blood and a lactate analyzer
|
Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CE2019/186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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