Cause and Consequence of Neural Fatigue
Fatstim
2 other identifiers
interventional
216
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 29, 2016
CompletedStudy Start
First participant enrolled
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 26, 2021
August 1, 2021
4.3 years
March 3, 2016
August 25, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
Proportion of chosen immediate reward in intertemporal questions between an immediate reward smaller than a delayed reward.
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).
Day 0
Physiological Measures: EEG
power of electrical brain oscillation.
Day 0
Physiological Measures: indirect calorimetry
volume of O2 consumption and CO2 expulsion.
day 0
Physiological Measures:pupillometry
pupil dilation.
Day 0
Study Arms (6)
Natural Fatigue
EXPERIMENTALBrain 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.
tDCS anodal
EXPERIMENTALBrain 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.
tDCS cathodal
EXPERIMENTALBrain 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.
tDCS sham
EXPERIMENTALBrain 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.
inhibitory TMS
EXPERIMENTALBrain 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.
Sham TMS
EXPERIMENTALBrain 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICM
Paris, 75013, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 29, 2016
Study Start
May 23, 2016
Primary Completion
September 1, 2020
Study Completion
December 1, 2020
Last Updated
August 26, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share