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
About this trial
This is an interventional basic science trial for Fatigue focused on measuring Fatigue, functional MRI
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
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
NCT ID
NCT02379013
First Posted
January 26, 2015
Last Updated
February 10, 2017
Sponsor
Hôpital NOVO
Collaborators
Paris West University Nanterre La Défense
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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