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临床试验/NCT04960540
NCT04960540Unknown不适用

Multimodal Brain Imaging Study of Language Cognitive Function in Patients With Amyotrophic Lateral Sclerosis

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
ALSFRS-R score

研究概览

简要总结

To explain the key brain network nodes and their brain mechanisms of ALS language cognitive impairment and decline, reveal the neural mechanism of the association between ALS language cognitive impairment and motor executive function, and provide potential early diagnostic markers and targeted therapeutic targets for ALS language cognitive impairment.

详细描述

【 Objective 】 To elucide the key brain network nodes and their brain mechanisms of language cognitive impairment and decline in ALS, and to reveal the neural mechanism of the association between language cognitive impairment and motor executive function in ALS, so as to provide potential early diagnostic markers and targeted therapeutic targets for language cognitive impairment in ALS.

[Design] With the help of multi-modal brain imaging methods such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, this project will analyze from multiple dimensions such as brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network.

In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data, To deeply understand the neural mechanism of language cognitive impairment in ALS patients.

The research will be divided into four parts, including: the brain functional network mechanism of ALS language understanding processing injury, ALS language use processing injury, ALS motor executive processing injury, ALS language cognitive injury brain structural network mechanism.

Ten patients with ALS were included in each part of the study, and 40 patients with ALS in four parts were included in the study. Multimodal magnetic resonance scanning and cognitive assessment were performed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Entry criteria:
  • Satisfied clinically possible ALS, laboratory supported suspected ALS, clinically suspected ALS or clinically confirmed ALS in the diagnostic criteria of ALS EL Escorial revised in 1998
  • Agree and sign the informed consent

排除标准

  • Severe respiratory dysfunction, unable to cooperate with NMR examination 2) Severe dysarthria and limb dysfunction, unable to cooperate with the neuropsychological examination 3) Patients with absolute or relative contraindications to MRI, including: a) Patients with cardiac pacemakers, cochlear implants, built-in pumps, nerve stimulators, artificial metal heart valves, etc.; B) After ligation of aneurysm clip (except non-paramagnetic, such as titanium alloy); C) Internal ferromagnetic metal implants (excluding metal IUD and fixed dentures); D) Claustrophobic; E) Patients with epilepsy 4) Pregnant patients 5) illiterate

结局指标

主要结局

ALSFRS-R score

时间窗: After 1 year of recruitment

Amyotrophic lateral sclerosis rating scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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