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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04005846
Other study ID # CE2019/186
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 1, 2019
Est. completion date April 15, 2023

Study information

Verified date May 2023
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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: 1. Is active tDCS applied bilaterally over the motor cortex significantly more efficient than sham tDCS to improve the TTE? 2. Does active tDCS decreases the RPE, as compared to sham? 3. 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? 4. 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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date April 15, 2023
Est. primary completion date April 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
Belgium ISEPK ULiège Liège

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Immediate
Secondary 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"). Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)
Secondary Maximal Oxygen Consumption (VO2max) evolution (active vs. sham) VO2max will be assessed continuously during the time to exhaustion trial using a gas analyzer Immediate
Secondary 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 Every 3 minutes during the test to exhaustion until the end of the test (up to 1 hour after the stimulation)
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