Spinal Cord Gray Matter Imaging in Post Polio Syndrome

• Conditions: Post-polio Syndrome
• Interventions: Other: magnetic resonance (MR) Imaging; Other: quantitative muscle force assessment

• Registration Number: NCT03561623
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2017-05-22
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-19
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	quantitative muscle force assessment	subjects age- and sex-matched; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment'
Healthy controls	magnetic resonance (MR) Imaging	subjects age- and sex-matched; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment'
Patients with Post Polio Syndrome	magnetic resonance (MR) Imaging	Post Polio syndrome diagnosed according to March of Dimes Criteria; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment'
Patients with Post Polio Syndrome	quantitative muscle force assessment	Post Polio syndrome diagnosed according to March of Dimes Criteria; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment'

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University Children's Hospital Basel; 🇨🇭 Basel, BS, Switzerland