Spinal Cord Gray Matter Imaging in Post Polio Syndrome

Quantitative Spinal Cord Gray Matter Imaging in Post Polio Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: Post-polio Syndrome
• Intervention / Treatment: Other: magnetic resonance (MR) Imaging; Other: quantitative muscle force assessment

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4031
      • University Children's Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Post Polio Syndrome; 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; MRI of spinal cord and brain; Other: quantitative muscle force assessment; quantitative assessment of muscle force
Healthy controls; subjects age- and sex-matched; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment'	Other: magnetic resonance (MR) Imaging; MRI of spinal cord and brain; Other: quantitative muscle force assessment; quantitative assessment of muscle force

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University Children's Hospital Basel
• Investigators: Principal Investigator: Regina Schlaeger, MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Central Nervous System Infections; Neurodegenerative Diseases; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Muscular Disorders, Atrophic; Myelitis; Syndrome; Poliomyelitis; Postpoliomyelitis Syndrome
• Other Study ID Numbers: PPS_Cord

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No