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临床试验/NCT03039166
NCT03039166Unknown不适用

Metabolic and Structural Characterization of Hub's Vulnerability in Neurological Diseases Assessed by Ultra High Field Structural and Functional MRI

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
260
试验地点
1
主要终点
Index of reorganization of the structural hubs (ks-Degree)

研究概览

简要总结

the investigators hypothesize that hub alteration occurs both in diffuse diseases (MS, AD) as well as in more 'network specific' diseases (Parkinson, ALS, Epilepsy). This could impact on functional dysfunction not directly related to each disease, but that could induce common syndrome such as cognitive impairment observed in Parkinson, partial epilepsy or ALS.

The objective here is to test this hypothesis and provides better understandings on pathophysiological processes affecting those highly connected regions in 'diffuse' and 'focal' neurological diseases.

The ultimate goal is to identify new clinical targets for trans-nosological approaches (DBS, cognitive rehabilitation ...).

Practically, the investigators will explore 200 patients classified in 5 cohorts of 40 patients suffering for MS, AD, Parkinson, ALS, Epilepsy, using the last advanced methods to assess structural and functional brain connectivity implemented on the human 7T MR scanner equipping the CEMEREM (CHU Timone, Marseille, only 50 similar MR scanners worldwide).

In addition to high resolution diffusion MRI and rs-fMRI, metabolic and ionic (sodium) mapping will complement the MR protocol to characterize the pathophysiological processes of hub injury. Sixty healthy controls will also be explored wih the same protocol for normal database.

The proposal aims at characterizing and comparing from a morphological-functional point of view, the hub regions of patients suffering from these five diseases, to demonstrate the pertinence to preserve hub integrity as a major therapeutic target whatever the disease.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Person female or male, more than 18-year-old,
  • •Person presenting unchecked general disease such as severe cancer, autoimmune disease, hepatic insufficiency, severe or untreated, shady arterial high blood pressure of the conduction or the disorder of the rhythm
  • •Person presenting chronic psychiatric disease, insane syndrome.
  • •Person presenting contraindication to the realization of an examination by MRI (metallic claustrophobia, foreign body, pacemakers),
  • •Person benefiting from a social security cover,
  • •Person having read, understood and signed an informed consent after information

排除标准

  • •Claustrophobia,
  • •Metallic foreign bodies,
  • •Pacemakers,
  • •Severe renal insufficiency

研究组 & 干预措施

healthy control patients

Active Comparator

干预措施: MRI 3 T (Device)

parkinson

Experimental

干预措施: MRI 7T (Device)

parkinson

Experimental

干预措施: MRI 3 T (Device)

partial epilepsy

Experimental

干预措施: MRI 7T (Device)

partial epilepsy

Experimental

干预措施: MRI 3 T (Device)

alzheimer disease

Experimental

干预措施: MRI 7T (Device)

alzheimer disease

Experimental

干预措施: MRI 3 T (Device)

multiple sclerosis

Experimental

干预措施: MRI 7T (Device)

multiple sclerosis

Experimental

干预措施: MRI 3 T (Device)

multiple sclerosis

Experimental

干预措施: blood sample (Biological)

amyotrophic lateral sclerosis

Experimental

干预措施: MRI 7T (Device)

amyotrophic lateral sclerosis

Experimental

干预措施: MRI 3 T (Device)

healthy control patients

Active Comparator

干预措施: MRI 7T (Device)

结局指标

主要结局

Index of reorganization of the structural hubs (ks-Degree)

时间窗: 5years

次要结局

  • cortical Thicknesses within hubs(5 years)
  • Iron accumulation within hubs(5 years)
  • Concentrations of sodium within hubs(5 years)
  • Concentrations of Glutamate/Glutamine within hubs(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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