Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis
研究概览
地位
条件
详细说明
Finger strength will be measure using a torque-measuring device designed to quantitate finger extension strength. The device was designed for point of treatment use, patient safety and portability. Strength will be measured in 5 paired trials, first with neck extended and then with neck flexed. Two protocols will be evaluated, one testing isometric strength against a fixed resistance and the second testing strength against dynamic resistance. McArdle's sign is the difference between strength with neck extension and strength with neck flexion.
The data will be digitally registered and dynamic neck position will be recorded electronically in real time. Graphs of dynamic changes in torque versus neck position will be generated and superimposed. Strength will be quantitated using Matlab software.
Consecutive patients with myelopathy of any cause with detectable finger extensor weakness will be studied, either due to MS or due to other cause of myelopathy (other inflammatory, vascular, compressive, neoplastic and other). Additionally, normal controls will be studied as will patients with finger extension weakness due to peripheral nerve lesions.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Myelopathy of any cause with finger extension weakness
- Patients with peripheral neuropathy with finger extension weakness
- Healthy controls
Exclusion Criteria:
- Pregnant subjects.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Myelopathy of any cause
Male or female 18 years or older with myelopathy and detectable finger extension weakness due to 1) prototypic multiple sclerosis (N=50) 2) other etiologies of myelopathy (N=50), including other inflammatory conditions (e.g.
idiopathic transverse myelitis, neuromyelitis optica, acute disseminated encephalomyelitis, sarcoidosis) or other etiologies (compression, vascular disorders, degenerative disorders, neoplasms).
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Peripheral neuropathy
Male or female 18 years or older with C7 radiculopathy, radial neuropathy, plexopathy, peripheral neuropathy, who have detectable finger extension weakness.
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Healthy Controls
Male and female 18 year or older with no finger extension weakness and no known neurological conditions.
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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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Difference in quantitative measure of strength between extended positions of the neck and fully flexed position of the neck (McArdle's sign)
大体时间：through study completion, an average of 1 year
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Comparison of means and medians of the difference in strength in the fully extended and fully flexed positions ("McArdle's sign") measured using a torque measurement device between multiple sclerosis versus other myelopathy and between multiple sclerosis and normal controls; measurements are done in 5 successive trials of extension and flexion and the mean percentage difference between extension and flexion of the last 4 trials is averaged to calculated the McArdle's sign; the goal is to determine whether there is a specific level of McArdle sign that is diagnostic for MS using receiver operator curve method.
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through study completion, an average of 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Relative sensitivity of clinical versus instrument-based detection of McArdle's sign.
大体时间：through study completion, an average of 1 year
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Compare the clinical detection of the sign by the referring clinician and technician compared to the device-determined McArdle's sign
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through study completion, an average of 1 year
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合作者和调查者
赞助
调查人员
- 首席研究员：Brian Weinshenker, MD、Mayo Clinic
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- 15-009122
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的设备产品
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