Post-polio Syndrome
Conditions
Brief summary
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
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.
Interventions
OTHERmagnetic resonance (MR) Imaging
MRI of spinal cord and brain
OTHERquantitative muscle force assessment
quantitative assessment of muscle force
Sponsors
University Children's Hospital Basel
University Hospital, Basel, Switzerland
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| spinal cord gray matter (GM) area measured by MRI | change between baseline and year 1 | Change in spinal cord cross-sectional gray matter area measured at baseline and at year 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in spinal cord white matter (WM) area measured by MRI | between baseline and year 1 | Change spinal cord cross-sectional white matter area |
| total spinal cord area measured by MRI | at baseline | spinal cord total cross-sectional area |
| Change in total spinal cord area measured by MRI | between baseline and year 1 | Change in spinal cord total cross-sectional area |
| spinal cord white matter (WM) area measured by MRI | at baseline | spinal cord cross-sectional white matter area |
| change in quantitative muscle strength measured by hand-held dynamometer | between baseline and year 1 | assessed by hand-held dynamometer |
| motor cortical thickness measured by MRI | at baseline | motor cortical thickness |
| Change in motor cortical thickness measured by MRI | between baseline and year 1 | Change in motor cortical thickness |
| quantitative muscle strength measured by hand-held dynamometer | at baseline | assessed by hand-held dynamometer |
Countries
Switzerland
Outcome results
None listed