Spinal Cord Gray Matter Imaging in Post Polio Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Quantitative Spinal Cord Gray Matter Imaging in Post Polio Syndrome

Conditions
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Post-polio Syndrome

Intervention / Treatment
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* Other: magnetic resonance (MR) Imaging
* Other: quantitative muscle force assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Ambulant Ability to walk 150 m in the 6 min walking distance (6MWT) with or without one or two walking sticks. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Post Polio Syndrome<br>Post Polio syndrome diagnosed according to March of Dimes Criteria; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment' | Other: magnetic resonance (MR) Imaging<br>* MRI of spinal cord and brain<br>Other: quantitative muscle force assessment<br>* quantitative assessment of muscle force<br>|
| Healthy controls<br>subjects age- and sex-matched; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment' | Other: magnetic resonance (MR) Imaging<br>* MRI of spinal cord and brain<br>Other: quantitative muscle force assessment<br>* quantitative assessment of muscle force<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spinal cord gray matter (GM) area measured by MRI | Change in spinal cord cross-sectional gray matter area measured at baseline and at year 1 | change between baseline and year 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spinal cord white matter (WM) area measured by MRI | spinal cord cross-sectional white matter area | at baseline | 
| change in spinal cord white matter (WM) area measured by MRI | Change spinal cord cross-sectional white matter area | between baseline and year 1 | 
| total spinal cord area measured by MRI | spinal cord total cross-sectional area | at baseline | 
| Change in total spinal cord area measured by MRI | Change in spinal cord total cross-sectional area | between baseline and year 1 | 
| quantitative muscle strength measured by hand-held dynamometer | assessed by hand-held dynamometer | at baseline | 
| change in quantitative muscle strength measured by hand-held dynamometer | assessed by hand-held dynamometer | between baseline and year 1 | 
| motor cortical thickness measured by MRI | motor cortical thickness | at baseline | 
| Change in motor cortical thickness measured by MRI | Change in motor cortical thickness | between baseline and year 1 |