Clinical trial NCT03561623: Spinal Cord Gray Matter Imaging in Post Polio Syndrome
Official title: Quantitative Spinal Cord Gray Matter Imaging in Post Polio Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-polio Syndrome
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2018-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 patients with Post-Polio Syndrome and 20 healthy age and sex matched control subjects were included in this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: spinal cord gray matter (GM) area measured by MRI
timeFrame: change between baseline and year 1
Secondary outcomes:
measure: spinal cord white matter (WM) area measured by MRI
timeFrame: at baseline
measure: change in spinal cord white matter (WM) area measured by MRI
timeFrame: between baseline and year 1
measure: total spinal cord area measured by MRI
timeFrame: at baseline
measure: Change in total spinal cord area measured by MRI
timeFrame: between baseline and year 1
measure: quantitative muscle strength measured by hand-held dynamometer
timeFrame: at baseline
measure: change in quantitative muscle strength measured by hand-held dynamometer
timeFrame: between baseline and year 1
measure: motor cortical thickness measured by MRI
timeFrame: at baseline
measure: Change in motor cortical thickness measured by MRI
timeFrame: between baseline and year 1
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
state: BS
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Regina Schlaeger, MD
role: PRINCIPAL_INVESTIGATOR
References: