EEG Monitoring for PERFormance Anticipation

Healthy Clinical Trial

— MEEGAPERF  

Official title:

Electrophysiological and Bioenergetic Study of Variations in Cognitive and Physical Performance in Healthy Humans: EEG Monitoring for PERFormance Anticipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233282
• Other study ID #: 69HCL16_0661
• Status: Completed
• Phase: N/A
• Start date: May 30, 2013
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Electroencephalography (EEG) multi-sensor
Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG), which is a non-invasive method.
• Magnetoencephalography (MEG)
Electrophysiological measurements of brain activity will be performed by magnetoencephalography (MEG) which is a non-invasive method.
• Behavioral Measures
The evaluation of cognitive performance will be carried out by means of behavioral measures, push-button type, handling of a mouse or a joystick.
• Reaction time measurement
The assessment of cognitive performance will be carried out using standard behavioral measures, such as reaction time measurement.
• Assessment of physical performance
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).
• Electrooculogram (EOG)
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.
• Electromyogram (EMG)
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.
• Electrocardiogram with 3 leads
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.
• Electrodermogram (EDG)
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.
• Consumption of O2 (VO2)
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.
• Production of CO2 (VCO2)
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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, HFME	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Refine (locate at the level of the cortex), the origin of these physiological markers	Several types of recordings, passive and non-invasive, will be realized: Electrooculogram (EOG); electromyography (EMG); electrocardiogram (ECG); Systematically in "physical" experiments and for some "cognitive" experiments.	7 hours
Secondary	Distinguish between different time scales of performance	Several types of recordings, passive and non-invasive, will be realized: electrodermogram (EDG); the consumption of O2 (VO2); production of CO2 (VCO2). Only and systematically, in "physical" experiments.	7 hours