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Cause and Consequence of Neural Fatigue (Fatstim)

Primary Purpose

Cognitive Fatigue

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Natural Fatigue
tDCS
TMS
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cognitive Fatigue

Eligibility Criteria

20 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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 ;

Sites / Locations

  • ICM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Natural Fatigue

tDCS anodal

tDCS cathodal

tDCS sham

inhibitory TMS

Sham TMS

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
Physiological Measures: EEG
power of electrical brain oscillation.
Physiological Measures: indirect calorimetry
volume of O2 consumption and CO2 expulsion.
Physiological Measures:pupillometry
pupil dilation.

Secondary Outcome Measures

Full Information

First Posted
March 3, 2016
Last Updated
August 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02721745
Brief Title
Cause and Consequence of Neural Fatigue
Acronym
Fatstim
Official Title
Cause and Consequence of Neural Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Natural Fatigue
Arm Type
Experimental
Arm Description
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.
Arm Title
tDCS anodal
Arm Type
Experimental
Arm Description
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.
Arm Title
tDCS cathodal
Arm Type
Experimental
Arm Description
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.
Arm Title
tDCS sham
Arm Type
Experimental
Arm Description
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.
Arm Title
inhibitory TMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham TMS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Natural Fatigue
Intervention Description
Experimental: EEG Indirect Calorimetry Pupillometry
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Experimental: EEG Indirect Calorimetry Pupillometry
Intervention Type
Device
Intervention Name(s)
TMS
Intervention Description
Experimental: EEG Indirect Calorimetry Pupillometry
Primary Outcome Measure Information:
Title
Proportion of chosen immediate reward in intertemporal questions between an immediate reward smaller than a delayed reward.
Description
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).
Time Frame
Day 0
Title
Physiological Measures: EEG
Description
power of electrical brain oscillation.
Time Frame
Day 0
Title
Physiological Measures: indirect calorimetry
Description
volume of O2 consumption and CO2 expulsion.
Time Frame
day 0
Title
Physiological Measures:pupillometry
Description
pupil dilation.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 ;
Facility Information:
Facility Name
ICM
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Cause and Consequence of Neural Fatigue

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