Quantitative Spinal Cord Gray Matter Imaging in Post Polio Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- spinal cord gray matter (GM) area measured by MRI
研究概览
简要总结
This is a longitudinal, observational study with the aims of comparing spinal cord gray matter areas in patients with Post-Polio Syndrome to age and sex matched healthy control subjects and to correlate atrophy with metrics of clinical disability.
详细描述
Post-Polio syndrome (PPS) is characterised by new muscle weakness, pain, and fatigue several years to decades after the acute polio infection. Pathomechanisms are not yet fully understood.
This is a longitudinal, observational study. The aims are (a) to detect spinal cord gray (and possibly) white matter atrophy in patients with Post Polio Syndrome in comparison to healthy age and sex matched control subjects both cross-sectionally and longitudinally and (b) to correlate spinal cord gray and white matter atrophy to metrics of clinical disability.
Investigators will assess 20 patients with Post-Polio syndrome and 20 control subjects at baseline and 48 weeks by MRI and clinically including quantitative muscle strength assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Prior paralytic poliomyelitis with evidence of motor neuron loss. This is confirmed by history of the acute paralytic illness, signs of residual weakness and atrophy of muscles on neuromuscular examination, and signs of motor neuron loss.
- •a period of partial or complete functional recovery after acute paralytic poliomyelitis, followed by an interval (usually 15 years or more) of stable neuromuscular function.
- •slowly progressive and persistent new muscle weakness or decreased endurance, with or without generalized fatigue, muscle atrophy, or muscle and joint pain. Symptoms that persist for at least a year.
- •Exclusion of other neuromuscular, medical, and skeletal abnormalities as causes of symptoms.
- •Patients older than 18 years at time of screening
- •Ability to walk 150 m in the 6 min walking distance (6MWT) with or without one or two walking sticks.
排除标准
- •Previous (3 months or less) or concomitant participation in any other therapeutic trial
- •known or suspected malignancy
- •Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator
结局指标
主要结局
spinal cord gray matter (GM) area measured by MRI
时间窗: change between baseline and year 1
Change in spinal cord cross-sectional gray matter area measured at baseline and at year 1
次要结局
- spinal cord white matter (WM) area measured by MRI(at baseline)
- change in quantitative muscle strength measured by hand-held dynamometer(between baseline and year 1)
- change in spinal cord white matter (WM) area measured by MRI(between baseline and year 1)
- motor cortical thickness measured by MRI(at baseline)
- total spinal cord area measured by MRI(at baseline)
- quantitative muscle strength measured by hand-held dynamometer(at baseline)
- Change in total spinal cord area measured by MRI(between baseline and year 1)
- Change in motor cortical thickness measured by MRI(between baseline and year 1)