Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

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追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

November 6, 2018

预计主要完成日期

November 6, 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Brain activity[ Time Frame: 1 hour ]

Brain parametric maps

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Brain connectivity[ Time Frame: 15 min ]
diffusion brain MRI (tractography)

描述性信息

简略标题 ^ICMJE

Brain Excitability and Connectivity in Sensory-motor Pathways in ALS

正式标题 ^ICMJE

Evaluation and Characterization of Infraclinical Sensory Deficits in Amyotrophic Lateral Sclerosis by Brain Imaging and Electrophysiology

简要概况

The main objective is to determine the origin of somatosensory alteration in patients with ALS and to evaluate its impact on brain activity by coupling different imaging modalities and indirect electrophysiology. The secondary objective is to evaluate whether the observed functional changes in MEG / EEG and functional MRI correlate with structural lesions revealed with diffusion MRI (anatomo-functional connectivity of the brain).

详细说明

Somatosensory evoked potentials (SEPs) produced by ulnar nerve electrical stimulation will be collected with combined MEG and EGG. Functional MRI will be performed during electrical stimulation of ulnar nerve and during mechanical vibration of ADM tendon. Brain diffusion MRI will be performed. Anatomical MRI will be done for source location. Brain resting state activity will be recorded with MEG/EEG and fMRI.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Non-Randomized
干预模型: Parallel Assignment
干预模型描述: patients vs. health subjects
盲法: Interventional
盲法描述:
主要目的: Basic Science

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: functional MRI
conditioning brain activity with peripheral stimulations
Device: structural MRI
diffusion MRI and tractography for evaluating the brain structures
Device: EEG/MEG
conditioning brain activity with peripheral stimulations

研究工具

Experimental: functional MRI
a group of patients with ALS and a group of gender and age matched healthy subjects will have functional MRI acquisition conditioned by electrical and mechanical stimuli of ADM proprioceptors
Experimental: structural MRI
a group of patients with ALS and a group of gender and age matched healthy subjects will have diffusion MRI acquisition to evaluate their brain structures
Experimental: EEG/MEG
a group of patients with ALS and a group of gender and age matched healthy subjects will have functional MRI acquisition conditioned by electrical stimuli of ADM proprioceptors

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

April 6, 2022

预计主要完成日期

November 6, 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - ALS, MRC score ≥ 4 at least in one hand - Controls: no history of neurological disorders, right-handed Exclusion Criteria: - contraindication to MRI

性别

参与研究的性别:

All

年龄

最小年龄：30 Years ，最大年龄：80 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

France

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Institut National de la Santé Et de la Recherche Médicale, France

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Pierre-Francois Pradat, MD, PhD Assistance Publique - Hôpitaux de Paris
Study Director: Veronique Marchand-Pauvert, PhD Institut National de la Santé Et de la Recherche Médicale, France

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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