Peripheral Nerve Ultrasound for Diagnosis and Prognosis of Guillain-Barre Syndrome: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls
研究概览
简要总结
The purpose of this study is to determine if peripheral nerve ultrasound can be used as a supplemental tool to diagnose Guillain-Barre syndrome (GBS) in the acute setting and aid in prognostication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
The EMG lab physician or technician performing the ultrasound will be blinded to the EMG/NCS results.
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
- •For GBS group: Inpatients with acute, progressive weakness and no alternative diagnosis, with onset less than 30 days prior to examination.
- •For control group: Hospitalized patients on the inpatient neurology service who are being treated for non-peripheral nerve disorders (e.g. epilepsy, multiple sclerosis, or stroke).
- •For all subjects: 18+ years of age
排除标准
- •Patients with any history of multifocal motor neuropathy (MMN), prior Guillain-Barre syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), or hereditary neuropathy (e.g. Charcot-Marie-Tooth)
结局指标
主要结局
Internerve Variability of Cross-sectional Area (CSA) in Patients With GBS vs Controls
时间窗: Day 0 and approximately 7 days after admission
Internerve CSA variability for each patient will be calculated as: maximal intranerve CSA variability/minimal intranerve CSA variability. Intranerve CSA variability for each nerve will be calculated as: maximal CSA/minimal CSA for median and ulnar nerves.
Median Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
时间窗: Day 0 and approximately 7 days after admission
Intranerve CSA variability for each nerve is calculated as: maximal intranerve CSA/minimal intranerve CSA . When both left and right ulnar nerves were scanned, the side with the largest intranerve CSA variability was used for analysis.
Ulnar Nerve Intranerve Cross-sectional Area (CSA) Variability in Patients With GBS vs Controls
时间窗: Day 0 and approximately 7 days after admission
Intranerve CSA variability for each nerve is calculated as: maximal intranerve CSA/minimal intranerve CSA . When both left and right ulnar nerves were scanned, the side with the largest intranerve CSA variability was used for analysis.
次要结局
- Length of Hospital Stay in Days(Up to approximately 20 days)
- Ambulatory Status on Discharge(At discharge, up to approximately 20 days)
- Respiratory Dysfunction, as Measured by Number of Days Intubated(During admission, up to approximately 20 days)
- Strength, as Measured by Hand Dynamometer(Day 0, Day 7)
- Strength, as Measured by Medical Research Council (MRC)(Day 0, Day 7)
- Number of Participants With Autonomic Dysfunction(During hospitalization, up to approximately 20 days)
- Disability as Measured by the Guillain-Barre Syndrome (GBS) Disability Score(Day 0, Day 7, Discharge (up to approximately 20 days), Day 90, Day 180)