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OpenTrials
Completed

NCT Number: NCT02721745

Cause and Consequence of Neural Fatigue

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.

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Key information

Conditions

Age range

20 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICM

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 ;

Treatment and study plan

Natural Fatigue

Behavioral

Experimental: EEG Indirect Calorimetry Pupillometry

tDCS

Device

Experimental: EEG Indirect Calorimetry Pupillometry

TMS

Device

Experimental: EEG Indirect Calorimetry Pupillometry

Primary outcomes

  1. Proportion of chosen immediate reward in intertemporal questions between an immediate reward smaller than a delayed reward.

    Time frame: Day 0

    Several questions between two options (an immediate reward and and a larger delayed reward) will be asked to the participants through a computer. The measure of impulsivity corresponds to the proportion of immediate reward that wil be chosen through the keyboard (left or right arrows).

  2. Physiological Measures: EEG

    Time frame: Day 0

    power of electrical brain oscillation.

  3. Physiological Measures: indirect calorimetry

    Time frame: day 0

    volume of O2 consumption and CO2 expulsion.

  4. Physiological Measures:pupillometry

    Time frame: Day 0

    pupil dilation.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Acronym: Fatstim

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2016
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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