Spinal Cord Gray Matter Imaging in Post Polio Syndrome

NCT ID: NCT03561623

Last Updated: 2020-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2022-10-31

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.

Conditions

Post-polio Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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'

magnetic resonance (MR) Imaging

Intervention Type: OTHER

MRI of spinal cord and brain

quantitative muscle force assessment

Intervention Type: OTHER

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'

magnetic resonance (MR) Imaging

Intervention Type: OTHER

MRI of spinal cord and brain

quantitative muscle force assessment

Intervention Type: OTHER

quantitative assessment of muscle force

Interventions

magnetic resonance (MR) Imaging

MRI of spinal cord and brain

Intervention Type: OTHER

quantitative muscle force assessment

quantitative assessment of muscle force

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Children's Hospital Basel

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Regina Schlaeger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Children's Hospital Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

PPS_Cord

Identifier Type: -

Identifier Source: org_study_id