Quatitative MRI of the Spinal Cord in Cervical Myelopathy: Assessment of Microstuctural Damage for Outcome Improvement

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 clinical damage, and to avoid surgical treatment in those who do not require it. Additionally, quantitative MRI, in combination with clinical data such as, neuromotor tests, could provide an important approach to assess the effectiveness of the therapeutical approach.

NCT Number	NCT06486038
Lead Sponsor	Istituto Clinico Humanitas Collaborators: Mediolanum Cardio Research
Conditions	Cervical Myelopathy
Enrollment	100 participants
Start Date	2024-04-03
Primary Completion	2025-05-31 (estimated)
Study Completion	2025-05-31 (estimated)
Updated on ClinicalTrials.gov	2024-07-10