Cause and Consequence of Neural Fatigue

NCT ID: NCT02721745

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-23

Study Completion Date

2020-12-31

Brief Summary

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While the scientific community understands quite well why muscles ache after prolonged exercise, the origins of mental fatigue remain totally mysterious. Existing theories remain at a psychological level, with scarce supporting evidence. Mental fatigue typically occurs after long episodes during which humans exert control on motor or cognitive processes, instead of executing routine or stimulus-driven behaviours. However, work organization (especially in risky job like airplane control or medical profession) and pathologies due to an overload of work (like burn-out) seems to be directly linked to neural fatigue. One of the consequences of neural fatigue is to alter decision-making. As an example, the choice between an immediate monetary reward and a larger but delayed monetary reward (the so called intertemporal choices) are susceptible to fatigue state of its underpinning neural network.

The investigators are proposing an exploratory study of neural fatigue, induced either in a natural way (by performing cognitive tasks for hours) or by transcranial stimulation, using three main physiological measures (Electro-encephalography to measure neural activity, indirect calorimetry to measure the metabolic cost of a cognitive effort, and pupillometry to measure cognitive effort).

This study should allow to better understand the consequences of neural fatigue on cognitive functions like decision making as well as the associated physiological variables.

Detailed Description

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Conditions

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Cognitive Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Natural Fatigue

Brain activity will be record through EEG (physiological measure),O2 consumption will be record through a metabolic monitor (physiological measure), or eye tracker according to the group.

Group Type EXPERIMENTAL

Natural Fatigue

Intervention Type BEHAVIORAL

Experimental: EEG Indirect Calorimetry Pupillometry

tDCS anodal

Brain activity will be record through EEG (physiological measure),O2 consumption will be record through a metabolic monitor (physiological measure), or eye tracker according to the group.

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Experimental: EEG Indirect Calorimetry Pupillometry

tDCS cathodal

Brain activity will be record through EEG (physiological measure),O2 consumption will be record through a metabolic monitor (physiological measure), or eye tracker according to the group.

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Experimental: EEG Indirect Calorimetry Pupillometry

tDCS sham

Brain activity will be record through EEG (physiological measure),O2 consumption will be record through a metabolic monitor (physiological measure), or eye tracker according to the group.

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

Experimental: EEG Indirect Calorimetry Pupillometry

inhibitory TMS

Brain activity will be record through EEG (physiological measure),O2 consumption will be record through a metabolic monitor (physiological measure), or eye tracker according to the group.

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

Experimental: EEG Indirect Calorimetry Pupillometry

Sham TMS

Brain activity will be record through EEG (physiological measure),O2 consumption will be record through a metabolic monitor (physiological measure), or eye tracker according to the group.

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

Experimental: EEG Indirect Calorimetry Pupillometry

Interventions

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Natural Fatigue

Experimental: EEG Indirect Calorimetry Pupillometry

Intervention Type BEHAVIORAL

tDCS

Experimental: EEG Indirect Calorimetry Pupillometry

Intervention Type DEVICE

TMS

Experimental: EEG Indirect Calorimetry Pupillometry

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Right-handed people;
* between 20 à 39 years old;
* able to understand the instructions and to perform the behavioral tasks of the study ;
* informed consent to take part to the study (signature of a a consent form);
* people being registered to social security or universal medical protection or equivalent;

Exclusion Criteria

For each experiment:

* neurological, psychiatric or serious illness history
* ongoing or recently stopped (lower than three weeks) psychotropic treatment;
* excessive psychotropic substances consumption or chronical consumption the examination day;
* People being not able to perform the tasks (alteration of one of the cognitive functions or elementary visual disorder avoiding the identification of the experimental stimuli);
* adult under legal protection (guardianship, or under the protection of a conservator);
* adult people being not able to express his consent;
* people being deprived of liberty as a consequence of an administrative or judicial decision;
* pregnant, parturient or nursing women;
* people taking part to another biomedical study or still being in the exclusion phase of another research;
* hospitalized people without consent;
* people who could not participate to the full study for any reasons.

For the experiments involving transcranial stimulation, in addition to the previous ones:

* take of drugs known to lower the epileptogenic threshold;
* take of barbiturate, gabapentin, topiramate, clonazepam in the 7 days before the first visit;
* history of awareness loss;
* people having contraindication for having a transcranial magnetic stimulation or for having an MRI examination;
* People who does not want to be informed of any significant irregularity that could be detected during the MRI examination;
* claustrophobic people ;
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ICM

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2015-A01445-44

Identifier Type: REGISTRY

Identifier Source: secondary_id

C15-59

Identifier Type: -

Identifier Source: org_study_id

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