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NCT Number: NCT02379013

Measure of Fatigue in Functional MRI

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

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volunteer with MRI

Procedure

functional MRI

Primary outcomes

  1. Assessment of executive function and circuit of functional MRI

    Time frame: 1 day

    Brain activity will be measured during tests to determine the central indices and peripheral quantitative and objectives of the state of fatigue.

Secondary outcomes

  1. Muscle strength measured with the electromyogram data

    Time frame: 1 day

    This outcome will be measured with the electromyogram data

  2. Saliva samples to measure the concentration of cortisol

    Time frame: 1 day

    Samples will be placed in tubes to be analysed to measure the concentration of cortisol.

  3. Assess attentional and executive functions (questionnaires)

    Time frame: 1 day

    Results of psychological (Mesulam, D2, Stroop) questionnaires

  4. Evaluation of voluntary satisfaction (questionnaire)

    Time frame: 1 day

    satisfaction questionnaire

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Collaborators

  • Paris West University Nanterre La Défense

Registry information

Official study title

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

Acronym: FATIGUE

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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