Cognitive FatigueFatstimNCT02721745

Cause and Consequence of Neural Fatigue

A study testing Natural Fatigue, tDCS and TMS in people with Cognitive Fatigue, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Cognitive Fatigue
What is being tested?: Natural Fatigue, tDCS and TMS
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 1 siteFrance
Study dates: 23 May 2016to Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 39 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

Who cannot join

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);

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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 ;

Trial locations and contacts

1 site in 1 country.

France1 site

ICM
Paris, 75013

Other trials in France

About this study

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.

Conditions: Cognitive Fatigue
Being tested: Natural Fatigue, tDCS, TMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Natural FatigueBehavioural
Experimental: EEG Indirect Calorimetry Pupillometry
tDCSDevice
Experimental: EEG Indirect Calorimetry Pupillometry
TMSDevice
Experimental: EEG Indirect Calorimetry Pupillometry

Study groups in NCT02721745
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: TMS

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Day 0
Physiological Measures: EEG
power of electrical brain oscillation.
Measured: Day 0
Physiological Measures: indirect calorimetry
volume of O2 consumption and CO2 expulsion.
Measured: day 0
Physiological Measures:pupillometry
pupil dilation.
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 2016Dec 2020

First posted29 Mar 2016 (estimated)
Study start23 May 2016
Primary completionSep 2020
Study completionDec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cognitive FatigueStudies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02721745
Sponsor's protocol ID: C15-59
Other IDs: 2015-A01445-44
Acronym: Fatstim
Status last verified: Aug 2021
First submitted: 3 Mar 2016
Last updated: 26 Aug 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cognitive Fatigue trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cause and Consequence of Neural Fatigue
ClinicalTrials.gov ID: NCT02721745
Acronym / sponsor ID: Fatstim / C15-59
Conditions: Cognitive Fatigue
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, FranceOther government
Study start: 23 May 2016 (actual)
Primary completion: Sep 2020 (actual)
Study completion: Dec 2020 (actual)
First posted: 29 Mar 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Natural Fatigue	Experimental	Behavioral: Natural FatigueBrain 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	Experimental	Device: tDCSBrain 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	Experimental	Device: tDCSBrain 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	Experimental	Device: tDCSBrain 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	Experimental	Device: TMSBrain 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	Experimental	Device: TMSBrain 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.

Who may qualify

Ages: 20 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (19 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Natural FatigueExperimental: EEG Indirect Calorimetry Pupillometry	Behavioural	Natural Fatigue
tDCSExperimental: EEG Indirect Calorimetry Pupillometry	Device	tDCS anodal, tDCS cathodal, tDCS sham
TMSExperimental: EEG Indirect Calorimetry Pupillometry	Device	Sham TMS, inhibitory TMS

Primary outcome

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).
Physiological Measures: EEG
Time frame: Day 0
power of electrical brain oscillation.
Physiological Measures: indirect calorimetry
Time frame: day 0
volume of O2 consumption and CO2 expulsion.
Physiological Measures:pupillometry
Time frame: Day 0
pupil dilation.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
Individual participant dataSharing planned: No

Related trials for Cognitive Fatigue

Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Natural Fatigue, tDCS and TMS in people with Cognitive Fatigue, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of chosen immediate reward in intertemporal questions between an immediate reward smaller than a delayed reward. (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02721745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.