- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03233282
EEG Monitoring for PERFormance Anticipation (MEEGAPERF)
September 30, 2025 updated by: Hospices Civils de Lyon
Electrophysiological and Bioenergetic Study of Variations in Cognitive and Physical Performance in Healthy Humans: EEG Monitoring for PERFormance Anticipation
Identify, characterize and then validate electrophysiological markers linking electrophysiological cerebral activity and performance in cognitive and physical fatigability in humans.
To do this, noninvasive explorations of electroencephalography (EEG) and magnetoencephalography (MEG) will be carried out under two conditions of different experiments, the first one that induces a cognitive fatigability and the second one that induces physical fatigability.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: Electroencephalography (EEG) multi-sensor
- Other: Magnetoencephalography (MEG)
- Other: Behavioral Measures
- Other: Reaction time measurement
- Other: Assessment of physical performance
- Other: Electrooculogram (EOG)
- Other: Electromyogram (EMG)
- Other: Electrocardiogram with 3 leads
- Other: Electrodermogram (EDG)
- Other: Consumption of O2 (VO2)
- Other: Production of CO2 (VCO2)
Study Type
Interventional
Enrollment (Actual)
169
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bron, France, 69500
- Hospices Civils de Lyon, HFME
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria MGPFco group:
- Adult subjects, male or female, right-handed or left-handed, from 18 years up to 70 years;
- Having duly completed the entire confidential medical questionnaire;
- Written consent of free, informed and express participation;
- No hearing problems;
- Having normal or corrected vision;
- Affiliation to a Social Security scheme.
Inclusion Criteria MGPFph group:
- Adult subjects, male or female, right-handed or left-handed, from 18 years up to 35 years;
- Practicing at least five hours of sports per week;
- Presenting a certificate of no contraindication to an exercise test, intense sports practice or an energy sport in competition of the current year;
- Having duly completed the entire confidential medical questionnaire;
- Without cardiovascular or motor disability;
- Without tumoral, inflammatory, cardiac, pulmonary, renal, digestive (malabsorption syndrome) or liver disease;
- Written consent of free, informed and express participation;
- Affiliation to a Social Security scheme.
Exclusion Criteria:
- Pregnant women, nursing mothers or those of childbearing age without contraception
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of liberty or of liberty
- Persons protected by the law
- Persons who have performed a maximum stress test within 15 days of the date of inclusion,
- In the course of drug treatments against indicated for the protocol (treatment for neurological diseases, psychiatric ...).
- Metal implants incompatible with MRI (for the subjects concerned, see appendices)
- Metallic implants incompatible with the MEG (for the subjects concerned, see appendices)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Cognitive Fatigability
|
Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG), which is a non-invasive method.
Electrophysiological measurements of brain activity will be performed by magnetoencephalography (MEG) which is a non-invasive method.
The evaluation of cognitive performance will be carried out by means of behavioral measures, push-button type, handling of a mouse or a joystick.
The assessment of cognitive performance will be carried out using standard behavioral measures, such as reaction time measurement.
The assessment of physical performance will be based both on bioenergetic measurements and on quantitative data collected in continuous and relative to the effort (eg instantaneous pedaling speed).
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
|
|
Other: Physical Fatigability
|
Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG), which is a non-invasive method.
Electrophysiological measurements of brain activity will be performed by magnetoencephalography (MEG) which is a non-invasive method.
The evaluation of cognitive performance will be carried out by means of behavioral measures, push-button type, handling of a mouse or a joystick.
The assessment of cognitive performance will be carried out using standard behavioral measures, such as reaction time measurement.
The assessment of physical performance will be based both on bioenergetic measurements and on quantitative data collected in continuous and relative to the effort (eg instantaneous pedaling speed).
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify electrophysiological markers in humans depending on whether the experimental conditions induce cognitive fatigability.
Time Frame: 7 hours
|
The evaluation of cognitive performance will be carried out by means of conventional behavioral measures, of the press-button type, handling of a mouse or of a joystick and measurement of reaction time.
|
7 hours
|
|
Identify electrophysiological markers in humans depending on whether the experimental conditions induce physical fatigability with EEG.
Time Frame: 7 hours
|
Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG).
|
7 hours
|
|
Identify electrophysiological markers in humans depending on whether the experimental conditions induce physical fatigability with MEG.
Time Frame: 7 hours
|
Electrophysiological measurements of cerebral activity will be carried out by magnetoencephalography (MEG)
|
7 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Refine (locate at the level of the cortex), the origin of these physiological markers
Time Frame: 7 hours
|
Several types of recordings, passive and non-invasive, will be realized:
|
7 hours
|
|
Distinguish between different time scales of performance
Time Frame: 7 hours
|
Several types of recordings, passive and non-invasive, will be realized:
|
7 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julien JUNG, MD, Hospices Civils de Lyon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Luc Poinsard, Christian Berthomier, Michel Clémençon, Marie Brandewinder, Slim Essid, Cécilia Damon, François Rigaud, Alexis Bénichoux, Emmanuel Maby, Lesly Fornoni, Patrick Bouchet, Pascal Van Beers, Bertrand Massot, Patrice Revol, Thomas Creveaux, Christian Collet, Jérémie Mattout, Vincent Pialoux and Véronique Billat. EEG-Metabolic Coupling and Time Limit at VO2max During Constant-Load Exercise. Journal of Functional Morphology and Kinesiology. 2025, 10, 369.
- Véronique Billat, Christian Berthomier, Michel Clémençon, Marie Brandewinder, Slim Essid, Cécilia Damon, François Rigaud, Alexis Bénichoux, Emmanuel Maby, Lesly Fornoni, Patrick Bouchet , Pascal Van Beers, Bertrand Massot, Patrice Revol, Luc Poinsard, Thomas Creveaux, Christian Collet, Jérémie Mattout and Vincent Pialoux. Electroencephalography Response during an Incremental Test According to the VO2max Plateau Incidence. Applied Sciences. 2024, 14, 5411.
- Seguin P, Maby E, Fouillen M, Otman A, Luaute J, Giraux P, Morlet D, Mattout J. The challenge of controlling an auditory BCI in the case of severe motor disability. J Neuroeng Rehabil. 2024 Jan 18;21(1):9. doi: 10.1186/s12984-023-01289-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 30, 2013
Primary Completion (Actual)
May 31, 2018
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
April 25, 2017
First Submitted That Met QC Criteria
July 25, 2017
First Posted (Actual)
July 28, 2017
Study Record Updates
Last Update Posted (Estimated)
October 3, 2025
Last Update Submitted That Met QC Criteria
September 30, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL16_0661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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