Condition: Cervical Myelopathy · Sponsor: Istituto Clinico Humanitas
The aim of this low interventional study is to detect microstructural degeneration prior to the presentation, worsening, or persistence following surgical or conservative treatment of cervical degenerative myelopathy signs and symptoms using quantitative imaging metrics and functional biometric analysis. The endpoints of the study are to collect and compare the clinical, biometric, neurophysiological and imaging data. The objectives of the study are: * to implement and validate a novel quantitative Magnetic Resonance (qMRI) protocol clinically for the identification and quantification of microstructural spinal cord damage * to compare qMRI data to clinical and neuromotor's and corresponding neurophysiological data * to create an integrated diagnostic tool for early diagnosis and disease monitoring of myelopathy, and for identification of a more reproducible and quantitative scale for assessing reversible and irreversible spinal cord damage combining clinical, biometric, imaging and neurophysiological data in patients suitable for surgical or non-surgical treatment. Patient will undergo: * MRI (baseline - 1 month- 6 months) * clinical data collection (baseline- 1 month - 6 months) * neuromotor assessment (baseline - 1 month - 6 months) * neurophysiological assessment (baseline - 6 months) * surgery if applicable Quantitative MRI of the spinal cord could provide a new objective system for identification of patients who require surgery before developing irreversible clinica…
This description comes directly from the study's public registry record.
Letterio S POLITI, MD · +390282245644 · letterio.politi@hunimed.eu
Luca A CAPPELLINI, MD · luca.cappellini@humanitas.it
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| IRCCS Istituto Clinico Humanitas | Rozzano, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06486038