NCT02721745

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 23, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

4.3 years

First QC Date

March 3, 2016

Last Update Submit

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

EXPERIMENTAL

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.

Behavioral: Natural Fatigue

tDCS anodal

EXPERIMENTAL

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.

Device: tDCS

tDCS cathodal

EXPERIMENTAL

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.

Device: tDCS

tDCS sham

EXPERIMENTAL

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.

Device: tDCS

inhibitory TMS

EXPERIMENTAL

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.

Device: TMS

Sham TMS

EXPERIMENTAL

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.

Device: TMS

Interventions

Natural FatigueBEHAVIORAL

Experimental: EEG Indirect Calorimetry Pupillometry

Natural Fatigue
tDCSDEVICE

Experimental: EEG Indirect Calorimetry Pupillometry

tDCS anodaltDCS cathodaltDCS sham
TMSDEVICE

Experimental: EEG Indirect Calorimetry Pupillometry

Sham TMSinhibitory TMS

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

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

Locations