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Measure of Fatigue in Functional MRI

Development and Evaluation of a Cognitive-motor System for a Quantitative and Objective Measure of Fatigue in Functional MRI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02379013
Acronym
FATIGUE
Enrollment
37
Registered
2015-03-04
Start date
2015-02-28
Completion date
2015-11-30
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue

Keywords

Fatigue, functional MRI

Brief summary

The purpose of this study is to determine more objective, central and peripheral indices of fatigue state by exploring the neural and behavioral correlates of the alert process while keeping the idea to corroborate these results with those obtained during the performance of physical exercises and neuropsychological tests classics of attention, motivation, and functions evaluation. The interest of this study is to manipulate and compare the phasic and tonic alert mechanism through the activation of an extrinsic motivational system during fatigue. The investigators have chosen the alert since it is a basic cognitive process defined as the ability to increase attentional resources with the expectation of a target stimulus resulting in reduced response time. It can be phasic (extrinsic), favored by the presence of a warning signal preceding the target (preparation time) or tonic (intrinsic) occurring without warning signal (wakefulness). The evaluation of the alert is classically realized by a simple reaction time task with the presence or not of warning signal soliciting wether the tonic alert or the phasic alert. The investigators suppose to revisit the healthy population with brain model alert issued in 2010 which highlighted the predominant role of the regions of the dorsolateral prefrontal cortex, parietal, cingulate and thalamus (non-motor) in maintaining attention and temporal preparation alert task. The investigators identify also functional, motor and cognitive components of basal ganglia of thalamus. Cognitive-motor paradigm and neurological dysfunctions observed in multiple sclerosis population will help to identify and separate the cognitive role and motor brain regions, particularly the thalamus and basal ganglia. New neurological hypotheses are proposed

Detailed description

This project will be applied on healthy subjects, and the subject will be equipped with two electrodes attached to the muscle of the left arm (flexor) to measure muscle activity. That will be performed with a handgrip (the subject press on the handgrip).The subject will receive two sessions. It will conduct a trial session in the laboratory to control his ability to imagine the task (imagination run) and perform the driving task correctly. Two saliva samples will be placed in tubes to be analysed to measure the concentration of cortisol before and after functional MRI. Then, psychological and satisfaction questionnaires will be completed by volunteers. This protocol will then be adapted and transferred to multiple sclerosis population (in a second study), for which fatigue is one of the symptoms most commonly reported.

Interventions

PROCEDUREVolunteer with MRI

functional MRI

Sponsors

Paris West University Nanterre La Défense
CollaboratorOTHER
Hôpital NOVO
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Male or female right-handed aged between 18 and 35 years * Free of neurological, psychiatric or abuse of alcohol or drugs * Affiliated with the social security system (beneficiary or legal) * Having understood the information and having signed the consent form

Exclusion criteria

* Against indication to 'MRI': Pacemaker or neurosensory pacemaker or implantable defibrillator, cochlear implants, Ocular or cerebral ferromagnetic foreign body near the nerve structures, metal prosthesis, Ventriculoperitoneal shunt valves neurosurgical, brace, Agitation of the patient: not cooperating or agitated subjects, low-age children, claustrophobic patient, expectant mother * Front-temporal dementia * Physical or psychiatric illness likely to interfere with the functional assessment

Design outcomes

Primary

MeasureTime frameDescription
Assessment of executive function and circuit of functional MRI1 dayBrain activity will be measured during tests to determine the central indices and peripheral quantitative and objectives of the state of fatigue.

Secondary

MeasureTime frameDescription
Muscle strength measured with the electromyogram data1 dayThis outcome will be measured with the electromyogram data
Saliva samples to measure the concentration of cortisol1 daySamples will be placed in tubes to be analysed to measure the concentration of cortisol.
Assess attentional and executive functions (questionnaires)1 dayResults of psychological (Mesulam, D2, Stroop) questionnaires
Evaluation of voluntary satisfaction (questionnaire)1 daysatisfaction questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026