NCT03233282

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

April 25, 2017

Last Update Submit

September 30, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Identify electrophysiological markers in humans depending on whether the experimental conditions induce cognitive fatigability.

    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.

    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.

    Electrophysiological measurements of cerebral activity will be carried out by magnetoencephalography (MEG)

    7 hours

Secondary Outcomes (2)

  • Refine (locate at the level of the cortex), the origin of these physiological markers

    7 hours

  • Distinguish between different time scales of performance

    7 hours

Study Arms (2)

Cognitive Fatigability

OTHER
Other: Electroencephalography (EEG) multi-sensorOther: Magnetoencephalography (MEG)Other: Behavioral MeasuresOther: Reaction time measurementOther: Assessment of physical performanceOther: Electrooculogram (EOG)Other: Electromyogram (EMG)Other: Electrocardiogram with 3 leads

Physical Fatigability

OTHER
Other: Electroencephalography (EEG) multi-sensorOther: Magnetoencephalography (MEG)Other: Behavioral MeasuresOther: Reaction time measurementOther: Assessment of physical performanceOther: Electrooculogram (EOG)Other: Electromyogram (EMG)Other: Electrocardiogram with 3 leadsOther: Electrodermogram (EDG)Other: Consumption of O2 (VO2)Other: Production of CO2 (VCO2)

Interventions

Electroencephalography (EEG) multi-sensorOTHER

Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG), which is a non-invasive method.

Cognitive FatigabilityPhysical Fatigability
Magnetoencephalography (MEG)OTHER

Electrophysiological measurements of brain activity will be performed by magnetoencephalography (MEG) which is a non-invasive method.

Cognitive FatigabilityPhysical Fatigability
Behavioral MeasuresOTHER

The evaluation of cognitive performance will be carried out by means of behavioral measures, push-button type, handling of a mouse or a joystick.

Cognitive FatigabilityPhysical Fatigability
Reaction time measurementOTHER

The assessment of cognitive performance will be carried out using standard behavioral measures, such as reaction time measurement.

Cognitive FatigabilityPhysical Fatigability
Assessment of physical performanceOTHER

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).

Cognitive FatigabilityPhysical Fatigability
Electrooculogram (EOG)OTHER

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.

Cognitive FatigabilityPhysical Fatigability
Electromyogram (EMG)OTHER

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.

Cognitive FatigabilityPhysical Fatigability
Electrocardiogram with 3 leadsOTHER

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.

Cognitive FatigabilityPhysical Fatigability
Electrodermogram (EDG)OTHER

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.

Physical Fatigability
Consumption of O2 (VO2)OTHER

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.

Physical Fatigability
Production of CO2 (VCO2)OTHER

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.

Physical Fatigability

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon, HFME

Bron, 69500, France

Location

Related Publications (3)

  • Poinsard L, Berthomier C, Clemencon M, Brandewinder M, Essid S, Damon C, Rigaud F, Benichoux A, Maby E, Fornoni L, Bouchet P, Beers PV, Massot B, Revol P, Creveaux T, Collet C, Mattout J, Pialoux V, Billat V. EEG-Metabolic Coupling and Time Limit at V O2max During Constant-Load Exercise. J Funct Morphol Kinesiol. 2025 Sep 26;10(4):369. doi: 10.3390/jfmk10040369.

    PMID: 41133559BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 38238759DERIVED

MeSH Terms

Interventions

MagnetoencephalographyOxygen Consumption

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMagnetometryInvestigative TechniquesMetabolism

Study Officials

  • Julien JUNG, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2017

First Posted

July 28, 2017

Study Start

May 30, 2013

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)