Prevalence of Orthostatic Tremor by Surface Electromyographic Recording in Patients Reporting Unsteadiness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of orthostatic tremor (OT
研究概览
简要总结
Clinical presentation of orthostatic tremor (OT) may be misleading and simply perceived by a postural instability such as in several peripheral neuropathies. In addition, peripheral neuropathies represent the leading cause of pathologies associated with OT. Among patients referred for an electroneuromyogram (ENMG) for peripheral neuropathy and presenting with postural unsteadiness, OT assessment will be systematically performed. Demographic, clinical and polygraphy characteristics of these patients will be analyzed and prevalence of OT in the general population of peripheral neuropathies will be assessed.
详细描述
Among patients who will be referred for ENMG and exploration of a neuropathy, orthostatic tremor will be investigated systematically.
Main objective and primary endpoint:
- To estimate the prevalence of OT with its 95% confidence interval in the population of patients defined above
- Presence of OT confirmed by surface EMG (polygraphy) in patients with standing instability referred for ENMG.
Secondary objectives and end points
- Determine the demographic, clinical, electrophysiological characteristics of patients with OT; Estimate the prevalence of peripheral neuropathy in patients with OT; Duration of symptoms; Correlation with quantitative neuropathy scores (ISS, MRC, ONLS, R-ODS)
- Age, sex, clinical parameters: symptoms reported by the patient (instability, tremor, weakness, pain, falls), duration, current medications, ISS score, MRC score, ONLS score, R-ODS score) and electrophysiological parameters (mean frequency of OT in Hertz, MUNIX score (number of motor units in the anterior tibialis, calculated by software on the ENMG machine).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •All patients complaining of instability when standing up and referred for an ENMG
- •Patient informed and having expressed his non-opposition to participating in the research
排除标准
- •Patient's refusal to participate in the study
- •Impossibility to stand
- •No affiliation to health insurance
- •Patients under a legal protection measure or unable to express their will
- •Patient under the State Medical Assistance (AME)
- •Patient under 18 years old
- •Pregnant women, parturients and breast-feeding mothers
结局指标
主要结局
Prevalence of orthostatic tremor (OT
时间窗: Day 0
Prevalence of OT (95% confidence interval) in patients complaining of postural instability and referred for ENMG
次要结局
- Rasch-built Overall Disability Scale (R-ODS) score(Day 0)
- Medical Research Council (MRC) score(Day 0)
- Inflammatory Neuropathy Cause and Treatment (INCAT) Sensory Sum Score (ISS) simplified(Day 0)
- Overall Neuropathy Limitations Scale (ONLS) score(Day 0)
- OT frequency(Day 0)
- Motor unit number index (MUNIX)(Day 0)