Post-polio SyndromeNCT03561623
Spinal Cord Gray Matter Imaging in Post Polio Syndrome
An observational study of Post-polio Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-polio Syndrome
- What is being tested?
- magnetic resonance (MR) Imaging and quantitative muscle force assessment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 May 2017to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 patients with Post-Polio Syndrome and 20 healthy age and sex matched control subjects were included in this study.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: 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.
Read the 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
- Being tested
- magnetic resonance (MR) Imaging, quantitative muscle force assessment
- Medical subject headings
- Postpoliomyelitis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance (MR) ImagingOther
MRI of spinal cord and brain
quantitative muscle force assessmentOther
quantitative assessment of muscle force
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: 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' Receives: Other: magnetic resonance (MR) Imaging; Other: quantitative muscle force assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change between baseline and year 1
Secondary outcomes (8)
spinal cord white matter (WM) area measured by MRI
spinal cord cross-sectional white matter area
Measured: at baseline
change in spinal cord white matter (WM) area measured by MRI
Change spinal cord cross-sectional white matter area
Measured: between baseline and year 1
total spinal cord area measured by MRI
spinal cord total cross-sectional area
Measured: at baseline
Change in total spinal cord area measured by MRI
Change in spinal cord total cross-sectional area
Measured: between baseline and year 1
quantitative muscle strength measured by hand-held dynamometer
assessed by hand-held dynamometer
Measured: at baseline
change in quantitative muscle strength measured by hand-held dynamometer
assessed by hand-held dynamometer
Measured: between baseline and year 1
motor cortical thickness measured by MRI
motor cortical thickness
Measured: at baseline
Change in motor cortical thickness measured by MRI
Change in motor cortical thickness
Measured: between baseline and year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start22 May 2017
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-polio SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Regina Schlaeger, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561623
- Sponsor's protocol ID
- PPS_Cord
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2018
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wendebourg MJ, Kesenheimer E, Sander L, Weigel M, Weidensteiner C, Haas T, Madoerin P, Diebold M, Deigendesch N, Neuhaus D, Naumann N, Neuwirth C, Braun N, Weber M, Granziera C, Scheurer E, Lenz C, Schweikert K, Sinnreich M, Lieb J, Bieri O, Schlaeger R. The Lateral Corticospinal Tract Sign: An MRI Marker for Amyotrophic Lateral Sclerosis. Radiology. 2024 Sep;312(3):e231630. doi: 10.1148/radiol.231630.
PubMed 39287519
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Spinal Cord Gray Matter Imaging in Post Polio Syndrome
- ClinicalTrials.gov ID
- NCT03561623
- Acronym / sponsor ID
- PPS_Cord
- Conditions
- Post-polio Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- 22 May 2017 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Post Polio Syndrome | – | Other: magnetic resonance (MR) Imaging, Other: quantitative muscle force assessmentPost Polio syndrome diagnosed according to March of Dimes Criteria; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment' |
| Healthy controls | – | Other: magnetic resonance (MR) Imaging, Other: quantitative muscle force assessmentsubjects age- and sex-matched; 'magnetic resonance (MR) Imaging' will be performed including a 'quantitative muscle force assessment' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with Post-Polio Syndrome and 20 healthy age and sex matched control subjects were included in this study.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance (MR) ImagingMRI of spinal cord and brain | Other | Healthy controls, Patients with Post Polio Syndrome |
| quantitative muscle force assessmentquantitative assessment of muscle force | Other | Healthy controls, Patients with Post Polio Syndrome |
Primary outcome
spinal cord gray matter (GM) area measured by MRI
Time frame: change between baseline and year 1
Change in spinal cord cross-sectional gray matter area measured at baseline and at year 1
8 secondary outcomes
spinal cord white matter (WM) area measured by MRI
Time frame: at baseline
change in spinal cord white matter (WM) area measured by MRI
Time frame: between baseline and year 1
total spinal cord area measured by MRI
Time frame: at baseline
Change in total spinal cord area measured by MRI
Time frame: between baseline and year 1
quantitative muscle strength measured by hand-held dynamometer
Time frame: at baseline
change in quantitative muscle strength measured by hand-held dynamometer
Time frame: between baseline and year 1
motor cortical thickness measured by MRI
Time frame: at baseline
Change in motor cortical thickness measured by MRI
Time frame: between baseline and year 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Derived from this study: PubMed 39287519Wendebourg MJ, Kesenheimer E, Sander L, Weigel M, Weidensteiner C, Haas T, Madoerin P, Diebold M, Deigendesch N, Neuhaus D, Naumann N, Neuwirth C, Braun N, Weber M, Granziera C, Scheurer E, Lenz C, Schweikert K, Sinnreich M, Lieb J, Bieri O, Schlaeger R. The Lateral Corticospinal Tract Sign: An MRI Marker for Amyotrophic Lateral Sclerosis. Radiology. 2024 Sep;312(3):e231630. doi: 10.1148/radiol.231630.
- Individual participant dataSharing planned: No
Related trials for Post-polio Syndrome
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Recruiting
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina Schlaeger, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-polio Syndrome, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spinal cord gray matter (GM) area measured by MRI (time frame: change between baseline and year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03561623, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.