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Measure of Fatigue in Functional MRI (FATIGUE)

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Volunteer with MRI
Sponsored by
Hôpital NOVO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fatigue focused on measuring Fatigue, functional MRI

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Volunteer with MRI

    Arm Description

    All volunteer will be included in the arm MRI

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Muscle strength measured with the electromyogram data
    This outcome will be measured with the electromyogram data
    Saliva samples to measure the concentration of cortisol
    Samples will be placed in tubes to be analysed to measure the concentration of cortisol.
    Assess attentional and executive functions (questionnaires)
    Results of psychological (Mesulam, D2, Stroop) questionnaires
    Evaluation of voluntary satisfaction (questionnaire)
    satisfaction questionnaire

    Full Information

    First Posted
    January 26, 2015
    Last Updated
    February 10, 2017
    Sponsor
    Hôpital NOVO
    Collaborators
    Paris West University Nanterre La Défense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02379013
    Brief Title
    Measure of Fatigue in Functional MRI
    Acronym
    FATIGUE
    Official Title
    Development and Evaluation of a Cognitive-motor System for a Quantitative and Objective Measure of Fatigue in Functional MRI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hôpital NOVO
    Collaborators
    Paris West University Nanterre La Défense

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue
    Keywords
    Fatigue, functional MRI

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Volunteer with MRI
    Arm Type
    Experimental
    Arm Description
    All volunteer will be included in the arm MRI
    Intervention Type
    Procedure
    Intervention Name(s)
    Volunteer with MRI
    Intervention Description
    functional MRI
    Primary Outcome Measure Information:
    Title
    Assessment of executive function and circuit of functional MRI
    Description
    Brain activity will be measured during tests to determine the central indices and peripheral quantitative and objectives of the state of fatigue.
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Muscle strength measured with the electromyogram data
    Description
    This outcome will be measured with the electromyogram data
    Time Frame
    1 day
    Title
    Saliva samples to measure the concentration of cortisol
    Description
    Samples will be placed in tubes to be analysed to measure the concentration of cortisol.
    Time Frame
    1 day
    Title
    Assess attentional and executive functions (questionnaires)
    Description
    Results of psychological (Mesulam, D2, Stroop) questionnaires
    Time Frame
    1 day
    Title
    Evaluation of voluntary satisfaction (questionnaire)
    Description
    satisfaction questionnaire
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alain LE BLANCHE, PUPH
    Organizational Affiliation
    Hôpital NOVO
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Measure of Fatigue in Functional MRI

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