NCT00393549终止3 期
NeuroPath Comparative Validation Study Plan
Excel-Tech Ltd.2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2006年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Validity of the NeuroPath
研究概览
简要总结
The purpose of the study is to compare the performance of the NeuroPath automated nerve conduction test with the standard of care manual test in the diagnosis of entrapment neuropathies.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic Inclusion Criteria:
- •sensory symptoms (numbness and/or tingling) in at least 2 of digits 1,2,3 and 4, in at least one hand, for at least 1 month, prior to the start of the clinical study. The sensory symptoms may be intermittent or constant, but if constant, there must have been a period of time during which the symptoms were intermittent. The numbness and tingling may be accompanied by pain, but pain alone is not sufficient to meet this first inclusion criteria.
- •Sensory symptoms (numbness and/or tingling) aggravated by at least 1 of the following: sleep, sustained hand or arm positioning, or repetitive actions of the hand.
- •Sensory symptoms (numbness and/or tingling) mitigated by at least 1 of the following: changes in hand posture, shaking the hand, or use of a wrist splint.
- •If pain is present, the wrist, hand, and finger pain is greater than elbow, shoulder, or neck pain if there is pain in any or all of those locations.
- •Symptomatic
排除标准
- •Sensory symptoms exclusive or predominatly in the little finger (D5) (ulnar neuropathy).
- •Neck pain or shoulder pain preceded the paresthesia in the digits (cervical radiculopathy and/or brachial plexopathy).
- •Numbness and/or tingling in the feet that preceded or accompanied the sensory symptoms in the hands (polyneuropathy).
- •Medical history and physical examination that indicates an explanation for the sensory symptoms which is more probable than CTS. For example, digital neuropathy, median nerve pathology proximal to the carpal tunnel, ulnar neuropathy, radical neuropathy, brachial plexopathy, cervical radiculopathy, spinal cord, brainstem or brain pathology, or a polyneuropathy.
- •Absence of 1st, 3rd, 4th or 5th digits
- •Open wounds at the measurement sites
- •Excessive sensitivity to electrical stimulation
- •Median nerve injection in the past 30 days
- •Prior carpal tunnel surgery
- •Patients who are susceptible to radio frequency noise - such as patients with pacemakers or patients that have electrical stimulators of any sort.
- •Control Subject Inclusion Criteria:
- •Normal neurological examination
- •Control Subject Exclusion Criteria:
- •Absence of 1st, 3rd or 5th digits
- •Open wounds at the measurement sites
- •Excessive sensitivity to electrical stimulation
- •Median nerve injection in the past 30 days
- •Prior carpal tunnel surgery
- •Reported history of CTS, polyneuropathy, diabetes,renal failure, thyroid disease or Vitamin B 12 deficiency
- •Patients who are susceptible to radio frequency noise-such as patients with pacemakers or patients that have electrical stimulators of any sort.
结局指标
主要结局
Validity of the NeuroPath
次要结局
- Accuracy of the NeuroPath
研究者
研究点 (2)
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