The main objective of this study is to compare DTI findings of PPS patients with those of healthy controls. Secondary objective of this study is to correlate DTI findings with clinical data such as isometric muscle strength. Third objective is to…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Muscle disorders
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint will be a characterization of changes in DTI parameters of
affected muscles, isometric muscle strength measurements (quadriceps) and a
full picture of the architectural organization of lower limb muscles and the
leg as a whole.
Secondary outcome
n/a
Background summary
Post-polio syndrome (PPS) is a condition that affects polio survivors years
after recovery from an initial acute attack of the poliomyelitis virus. In
2010, 12-20 million people worldwide suffered from late sequelae of
poliomyelitis. One of the main symptoms is progressive muscle weakness. Besides
physical problems, patients also deal with mental fatigue and lower quality of
life.
The pathophysiological mechanism behind PPS is not fully understood, and there
is no specific treatment. Therapeutic interventions are mainly focused on
adaptive measures, physical therapy and symptom relief. Pharmacological
treatments are still experimental.
There is great need for quantitative information on the disease progression and
the process of skeletal muscle plasticity, which can consequently improve
treatment monitoring and enable intensified tailored physical therapy.
Diffusion Tensor Imaging (DTI) is a Magnetic Resonance Imaging (MRI) technique
that is able to characterize muscle and nerve fiber architecture as well as to
provide insights in local histopathological status of nerve and muscle tissue.
Study objective
The main objective of this study is to compare DTI findings of PPS patients
with those of healthy controls. Secondary objective of this study is to
correlate DTI findings with clinical data such as isometric muscle strength.
Third objective is to define the reproducibility of DTI in muscle tissue.
In this research we do not aim to replace isometric strength measurements by
DTI, but to assess the feasibility of DTI as a tool to provide quantitative and
reproducible information on the disease progression and skeletal muscle
plasticity, as well as to improve knowledge on the pathophysiology of PPS.
Study design
Observational study
Study burden and risks
Patients will undergo and MRI scan of the legs twice and isometric muscle
strength testing of the quadriceps once (approximately 1 hour per part). Study
subjects have to visit the AMC twice. Burden for study subjects is minimal.
Isometric muscle strength measurements do not pose any risk to the study
subjects.
Risks for subjects undergoing MRI examination are minimal, provided precautions
have been made to prevent examining individuals with contraindications. For
this purpose, the routine MRI contra indications form of the AMC will be used.
If the subject has a prosthesis, he/she is only included if the prosthesis
serial number can be acquired since recent prostheses are not a
contraindication for MRI.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
PPS patients:
Subject has symptomatic quadriceps deterioration, evidence of enlarged motor units (as measured by high-density surface EMG) and isometric quadriceps muscle strength of >=30Nm in at least one leg. Subject has symptoms for >= 1 year that cannot be explained by any other neurological disorder
Healthy controls: Subject is free of symptoms that can be explained by any neurological disorder
Exclusion criteria
PPS patients & healthy controls:
Subject is unwilling or unable to participate in this study and to give informed consent. Subject is also excluded if prosthesis registration number cannot be acquired (relatively new prostheses are not a contra-indication for MRI, this can be checked with the prosthesis registration number) (If applicable). Other exclusion criteria are contra-indications to undergo an MRI scan (pregnancy, claustrophobia, metal corpora aliena or metal implants such as pacemakers)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43077.018.12 |