NCT02011204已完成不适用
Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Skulpt, Inc.
- 入组人数
- 106
- 试验地点
- 6
- 主要终点
- Discrimination between Groups
研究概览
简要总结
This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue.
详细描述
This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will be studied:
- Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes;
- Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care; and,
- Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held Dynamometry (HHD) and Vital Capacity (VC) measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sporadic or familial ALS (as defined by revised El Escorial criteria)
- •Onset of weakness or spasticity due to ALS ≤ 36 months prior to the Screening/Baseline Visit.
- •Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age
排除标准
- •The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
- •ALS Disease Mimics Inclusion Criteria:
- •Diagnosis of one of the following:
- •a. Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii. Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness involving more than one extremity or more than a single myotome if restricted to one extremity.
- •iv. Multiple peripheral mononeuropathies with clinical weakness v. Charcot-Marie-Tooth Disease vi. Any condition that produces generalized or localized weakness without concomitant sensory symptoms, including myasthenia gravis or myopathy, that the evaluating physician deems mimics ALS.
- •b. Pure Upper Motor Neuron Disease (UMND) mimics: i. Cervical myelopathy ii. Multiple sclerosis iii. Hereditary spastic paraparesis
- •ALS Disease Mimics Exclusion Criteria:
- •Diagnosis of possible, probable, probable-laboratory supported, or definite ALS
- •Presence of positive family history of ALS.
- •The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
- •Healthy Volunteer Inclusion Criteria:
- •Absence of a known neurological disorder.
- •Healthy Volunteer Exclusion Criteria:
- •History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative disease.
- •Presence of positive family history of ALS.
- •The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, or a history of active substance abuse within the prior year.
- •*Please note that this is not a complete listing on all eligibility criteria.*
结局指标
主要结局
Discrimination between Groups
时间窗: Duration of the Study (9 months for Group A, one visit for Groups B and C)
Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes
次要结局
- Tracking Progression(Duration of Study, (9 months for Group A, one visit for Groups B and C))
- Correlation with Outcome Measures(Duration of Study (9 months for Group A, one visit for Groups B and C))
研究者
研究点 (6)
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