Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis
2018年6月4日 更新者：University of Michigan
Study the cervical spinal cord and brain over time to assess changes and differences in subjects with amyotrophic lateral sclerosis.
研究概览
详细说明
Investigators will study cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant compared to ALS patients who have not had a stem cell transplant.
Investigators intend to determine cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant and compare these to corresponding measures in amyotrophic lateral sclerosis(ALS) patients who have not had a stem cell transplant.
研究类型
介入性
注册 (实际的)
6
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 years of age or older
- Subjects with amyotrophic lateral sclerosis -
Exclusion Criteria:
- Do not have opportunistic central nervous system infection
- Do not have a history of head injury
- Do not have cerebrovascular disease
- Do not have a contraindication for MRI(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
- Must not be pregnant -
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：ALS patients receivng stem cells
Amyotrophic lateral sclerosis(ALS)subjects, who will be receiving stem cells, will undergo a brief clinical evaluation and questionnaire that will last approximately 20 to 30 min.
Subjects will be asked to undergo magnetic resonance imaging(MRI)scans of the cervical spine and brain that will last approximately 60 minutes.
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Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells.
This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
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有源比较器：ALS patients not receiving stem cells
Amyotrophic lateral sclerosis(ALS)patient who will not be receiving stem cells, will have an MRI that lasts approximately 60 minutes.
This MRI will be repeated at three different time points.
Subjects will have an initial MRI, then another at both 6 and 12 months after the initial magnetic resonance imaging(MRI)scan.
Subjects will also complete a clinical examination which will take approximately 30 minutes for each MRI.
The follow-up magnetic resonance imaging(MRI)scans done for ALS patients who do not receive stem cells are part of routine clinical studies and therefore subjects will not be billed.
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Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells.
This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in spinal cord metabolites in treated ALS subjects and nontreated ALS subjects.
大体时间：5 years
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1.
The longitudinal changes in spinal cord metabolites in amyotrophic lateral sclerosis(ALS) stem cell treated patients will be compared to amyotrophic lateral sclerosis(ALS) non-treated patients using magnetic resonance spectroscopy.
Investigators hypothesize that amyotrophic lateral sclerosis(ALS) stem cell treated patients will demonstrate attenuated rates of decline in the levels of N-acetylaspartate(NAA), a measure of neuronal integrity, in the cervical spinal cord than amyotrophic lateral sclerosis(ALS) non-treated patients.
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5 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Bradley Foerster, M.D.、University of Michigan Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年11月1日
初级完成 (实际的)
2015年9月30日
研究完成 (实际的)
2015年9月30日
研究注册日期
首次提交
2013年11月8日
首先提交符合 QC 标准的
2014年2月6日
首次发布 (估计)
2014年2月10日
研究记录更新
最后更新发布 (实际的)
2018年6月6日
上次提交的符合 QC 标准的更新
2018年6月4日
最后验证
2018年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.