Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)
2021年3月24日 更新者：NYU Langone Health
Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis
Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age.
Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management.
First is the absence of a sensitive and precise measure of cognitive impairment.
Second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance.
This project overcomes both obstacles to link cognitive impairment to MS disease biomarkers.
The absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (MS).
This project overcomes both obstacles to link cognitive function to MS disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (Tecfidera) for preserving cognitive function.
研究概览
地位
终止
研究类型
观察性的
注册 (实际的)
6
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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New York
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New York、New York、美国、10016
- New York University School of Medicine
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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 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
20 MS participants and 10 healthy controls.
However, the data analysis is planned for 15 MS participants and 10 healthy control participants.
It is expected that 15 MS subjects and 10 healthy controls will complete 12 months.
描述
Inclusion Criteria:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Male and Female subjects between 18 and 45 years
- WRAT-4 Reading [127] standard score > 85
- Able to undergo neuroimaging data collection procedures. For MS Participants
- Definite diagnosis of RRMS [128]
- EDSS of 0 to 6.0
- Adequate vision as as reported by the participant (with correction if applicable)
- Clinically prescribed Tecfidera, Tysabri or Ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit
- At baseline visit, concurrent medications to be kept constant over three months prior to data collection visits
- No relapse or steroids in previous month
Exclusion Criteria:
- Unable or unwilling to provide informed consent.
- Beck Depression Inventory-Fast Screen (BDI-FS) [129, 130] score of 4 or more
- Current alcohol or other substance use disorder
- Primary psychiatric disorder that would adversely influence ability to participate
- Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
- Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
- Learned English language after 12 years of age
For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.
For MS participants:
- Lemtrada, Cladribine, Mitoxantrone
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
MS Patients
Definite diagnosis of RRMS
|
5mCi of the radiotracer FDG administered intravenously as a bolus over 30s.
After injection, emission data will be collected for 60 min,
High-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence.
Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought.
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
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Healthy Controls
gender aged match healthy
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5mCi of the radiotracer FDG administered intravenously as a bolus over 30s.
After injection, emission data will be collected for 60 min,
High-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence.
Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought.
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
|
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 |
|---|---|---|
|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
大体时间：Baseline
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
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Baseline
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intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
大体时间：3 Months
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Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
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3 Months
|
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intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
大体时间：6 Months
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
|
6 Months
|
|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
大体时间：9 Months
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
|
9 Months
|
|
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
大体时间：12 Months
|
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
|
12 Months
|
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：Leigh Charvet、NYU Langone Health
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 (实际的)
2018年7月1日
初级完成 (实际的)
2021年1月9日
研究完成 (实际的)
2021年1月9日
研究注册日期
首次提交
2018年9月27日
首先提交符合 QC 标准的
2018年10月25日
首次发布 (实际的)
2018年10月29日
研究记录更新
最后更新发布 (实际的)
2021年3月26日
上次提交的符合 QC 标准的更新
2021年3月24日
最后验证
2021年3月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 17-00238
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD 共享时间框架
Beginning 3 months and ending 5 years following article publication.
IPD 共享访问标准
Researchers who provide a methodologically sound proposal.
IPD 共享支持信息类型
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Siemens Biograph mMR (molecular MR)的临床试验
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University Hospital Inselspital, BerneSwiss National Science Foundation招聘中