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临床试验/NCT00809224
NCT00809224已完成不适用

Tracking Brain Changes During Real and Imagined Movements in People With ALS (Lou Gehrig's Disease) and Healthy Volunteers.

University of Michigan1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
cortical activation patterns

研究概览

简要总结

The purpose of this study is to track areas of the brain, via functional magnetic resonance imaging (fMRI), that retain structural and functional integrity throughout the lifespan of people with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

详细描述

A severe physical disability has a dramatic impact on a person's life, whether it is caused by a neuro-degenerative disease such as amyotrophic lateral sclerosis (ALS), a brainstem stroke, or a spinal cord injury. Someone with these conditions may be effectively "locked-in," retaining their cognitive ability, but unable to perform any movement except, possibly, the most basic eye movements.

Areas of the brain that retain structural and functional integrity throughout the lifespan of people with ALS may be suitable for a technology called brain-computer interfaces (BCI). One day, BCIs-which can be operated "just by thinking"-may allow people with neurological disorders, such as ALS, to communicate and regain some mobility with the assistance of electronic devices.

In this study we will use functional magnetic resonance imaging (fMRI) to track areas of the brain that retain structural and functional integrity throughout the lifespan of people with ALS.

The trial involves visits to the study facility every 2-6 months for up to 30 months or until visits are no longer possible. During each visit, participants will undergo a fMRI exam. During that time they will view visual images and be asked to perform 4 different motor tasks: 1) actual finger tapping, 2) actual fist clenching, 3) imaginary finger tapping, and 4) imaginary fist clenching. Each of the mini-experiments (tasks) lasts for about 6-7 minutes. While the participants are performing the tasks their brains will be repeatedly imaged using fMRI. We will then use the images to look for correlations to the tasks, which in turn will result in identifying the brain areas responsible for the activities. After the fMRI, participants will be asked to fill out questionnaires. Performing the tasks takes about 90 minutes and filling out the questionnaires takes about 30 minutes.

The facility is located on the North Campus of the University of Michigan-Ann Arbor. The study coordinators currently are enrolling participants with ALS and creating a database of healthy volunteers whom they will contact at a later date.

研究设计

研究类型
Observational
观察模型
Case Control

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
是

入选标准

  • •Participants with and without ALS must:
  • •be between 18 and 70 years of age
  • •not be claustrophobic
  • •not have metal particles in their eyes
  • •not have metal implants (joints, inner ear, pacemaker, etc.) or foreign metal in their body
  • •not have a history of neurological or psychiatric disorder
  • •not have a history of alcohol or drug abuse
  • •be able to lie on their back for 90 minutes
  • •not be dependent on artificial ventilation
  • •not be on PiPap, or must be capable of being off it for greater than 6 hours
  • •healthy controls must be over the age of 40

排除标准

  • 未提供

结局指标

主要结局

cortical activation patterns

时间窗: Yearly

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Welsh

Research Associate Professor

University of Michigan

研究点 (1)

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