Spinal Cord Gray Matter Imaging in Post Polio Syndrome

NCT03561623 | Unknown

• 1 other identifier: PPS_Cord
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-polio Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• spinal cord white matter (WM) area measured by MRI

  at baseline

• change in spinal cord white matter (WM) area measured by MRI

  between baseline and year 1

• total spinal cord area measured by MRI

  at baseline

• Change in total spinal cord area measured by MRI

  between baseline and year 1

• quantitative muscle strength measured by hand-held dynamometer

  at baseline

Study Arms (2)

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; Other: quantitative muscle force assessment

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; Other: quantitative muscle force assessment

Interventions

magnetic resonance (MR) Imaging OTHER

MRI of spinal cord and brain

Healthy controls; Patients with Post Polio Syndrome

quantitative muscle force assessment OTHER

quantitative assessment of muscle force

Healthy controls; Patients with Post Polio Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University Children's Hospital Basel: collaborator

Study Sites (1)

University Children's Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Postpoliomyelitis Syndrome

Interventions

Magnetic Resonance Spectroscopy; X-Rays

Condition Hierarchy (Ancestors)

Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Regina Schlaeger, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 19, 2018
• Study Start: May 22, 2017
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)