Spinal Cord Gray Matter Imaging in Post Polio Syndrome

Post-polio Syndrome Clinical Trial

Official title:

Quantitative Spinal Cord Gray Matter Imaging in Post Polio Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03561623
• Other study ID #: PPS_Cord
• Status: Active, not recruiting
• Start date: May 22, 2017
• Est. completion date: October 2022

Study information

• Verified date: June 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Poliomyelitis
• Post-polio Syndrome
• Postpoliomyelitis Syndrome
• Syndrome

Intervention

Other:
• magnetic resonance (MR) Imaging
MRI of spinal cord and brain
• quantitative muscle force assessment
quantitative assessment of muscle force

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	spinal cord white matter (WM) area measured by MRI	spinal cord cross-sectional white matter area	at baseline
Secondary	change in spinal cord white matter (WM) area measured by MRI	Change spinal cord cross-sectional white matter area	between baseline and year 1
Secondary	total spinal cord area measured by MRI	spinal cord total cross-sectional area	at baseline
Secondary	Change in total spinal cord area measured by MRI	Change in spinal cord total cross-sectional area	between baseline and year 1
Secondary	quantitative muscle strength measured by hand-held dynamometer	assessed by hand-held dynamometer	at baseline
Secondary	change in quantitative muscle strength measured by hand-held dynamometer	assessed by hand-held dynamometer	between baseline and year 1
Secondary	motor cortical thickness measured by MRI	motor cortical thickness	at baseline
Secondary	Change in motor cortical thickness measured by MRI	Change in motor cortical thickness	between baseline and year 1