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临床试验/NCT01995903
NCT01995903已完成不适用

Developing a Discrimination Model to Diagnose ALS Using Advanced MRI Techniques

University of Michigan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Developing a Discrimination Model to Diagnose ALS

研究概览

简要总结

To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis.

详细描述

Early diagnosis and lack of understanding of the pathophysiology of ALS remain a significant obstacle to making a timely intervention to help patients suffering from this fatal disease. We envision a future in which neuroimaging techniques will be a critical tool in the diagnostic work-up of ALS. Advanced neuroimaging techniques offer great potential in identifying central nervous system metabolite and cellular alterations in ALS. We propose an innovative approach to combine complementary advanced MRI techniques to interrogate brain chemistry (MRS), brain microstructure (DTI) and brain function (fcMRI) and develop a clinically relevant discriminatory disease model.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •18 years of age or older
  • •subjects with ALS (amyotrophic lateral sclerosis)
  • •healthy subjects -

排除标准

  • •Active substance abuse
  • •Has co-morbid psychiatric disease
  • •Has opportunistic CNS (central nervous system) infection
  • •Has a history of head injury
  • •Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)

研究组 & 干预措施

Amyotrophic lateral sclerosis

Experimental

Clinical examination for ALS(amyotrophic lateral sclerosis) and subjects with lower motor neuron signs will be completed. These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to assess neurological conditions.

干预措施: MRI(magnetic resonance imaging) (Diagnostic Test)

Healthy controls (MRI)

Active Comparator

These subjects will undergo MRI (magnetic resonance imaging) scans of the brain to compare against diseased subjects.

干预措施: MRI(magnetic resonance imaging) (Diagnostic Test)

结局指标

主要结局

Developing a Discrimination Model to Diagnose ALS

时间窗: 5 years

We will measure brain fractional anisotropy (unitless) using diffusion tensor imaging of ALS patients and compare these to corresponding measures in healthy control subjects as well as patients with lower motor neuron signs only.

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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