An interventional study of Volunteer with MRI in Fatigue, sponsored by Hôpital NOVO. Completed. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-13.
Sponsored by Hôpital NOVO · Not applicable, Interventional, and Basic science
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
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.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 37 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Hôpital NOVO is the lead sponsor of 69 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All volunteer will be included in the arm MRI
Procedure: Volunteer with MRI
functional MRI
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.
Time frame: 1 day
Muscle strength measured with the electromyogram data
This outcome will be measured with the electromyogram data
Time frame: 1 day
Saliva samples to measure the concentration of cortisol
Samples will be placed in tubes to be analysed to measure the concentration of cortisol.
Time frame: 1 day
Assess attentional and executive functions (questionnaires)
Results of psychological (Mesulam, D2, Stroop) questionnaires
Time frame: 1 day
Evaluation of voluntary satisfaction (questionnaire)
satisfaction questionnaire
Time frame: 1 day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hôpital NOVO