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Measure of Fatigue in Functional MRI (FATIGUE)

2017年2月10日 更新者:Centre Hospitalier René Dubos

Development and Evaluation of a Cognitive-motor System for a Quantitative and Objective 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

研究概览

地位

完全的

条件

详细说明

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.

研究类型

介入性

注册 (实际的)

37

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Volunteer with MRI
All volunteer will be included in the arm MRI
functional MRI

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assessment of executive function and circuit of functional MRI
大体时间:1 day
Brain activity will be measured during tests to determine the central indices and peripheral quantitative and objectives of the state of fatigue.
1 day

次要结果测量

结果测量
措施说明
大体时间
Muscle strength measured with the electromyogram data
大体时间:1 day
This outcome will be measured with the electromyogram data
1 day
Saliva samples to measure the concentration of cortisol
大体时间:1 day
Samples will be placed in tubes to be analysed to measure the concentration of cortisol.
1 day
Assess attentional and executive functions (questionnaires)
大体时间:1 day
Results of psychological (Mesulam, D2, Stroop) questionnaires
1 day
Evaluation of voluntary satisfaction (questionnaire)
大体时间:1 day
satisfaction questionnaire
1 day

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Alain LE BLANCHE, PUPH、Centre Hospitalier René Dubos

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年2月1日

初级完成 (实际的)

2015年11月1日

研究完成 (实际的)

2015年11月1日

研究注册日期

首次提交

2015年1月26日

首先提交符合 QC 标准的

2015年3月3日

首次发布 (估计)

2015年3月4日

研究记录更新

最后更新发布 (实际的)

2017年2月13日

上次提交的符合 QC 标准的更新

2017年2月10日

最后验证

2017年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CHRD0714

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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