Measure of Fatigue in Functional MRI

NCT02379013 | Completed

• 1 other identifier: CHRD0714
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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

Conditions

Fatigue

Keywords

Fatigue; functional MRI

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (4)

• Muscle strength measured with the electromyogram data

  1 day

• Saliva samples to measure the concentration of cortisol

  1 day

• Assess attentional and executive functions (questionnaires)

  1 day

• Evaluation of voluntary satisfaction (questionnaire)

  1 day

Study Arms (1)

Volunteer with MRI

EXPERIMENTAL

All volunteer will be included in the arm MRI

Procedure: Volunteer with MRI

Interventions

Volunteer with MRI PROCEDURE

functional MRI

Volunteer with MRI

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital NOVO: lead
• Paris West University Nanterre La Défense: collaborator

MeSH Terms

Conditions

Fatigue

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Alain LE BLANCHE, PUPH

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: March 4, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 13, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share