Quatitative MRI of the Spinal Cord in Cervical Myelopathy: Assessment of Microstuctural Damage for Outcome Improvement
Trial ID: NCT06486038
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-04-03
Completion date: 2025-05-31
Sponsor: Istituto Clinico Humanitas
Collaborators: Mediolanum Cardio Research
Conditions: Cervical Myelopathy
Interventions: MRI standard and qMRI; MEPs and SSEPs; Neuromotor assessment; Anterior cervical discectomy and fusion
Locations: IRCCS Istituto Clinico Humanitas
Countries: Italy
Enrollment: 100
Age range: 18 Years - 80 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

1. Subjects willing and able to give informed consent for participation in the study.
2. Age 18-80.
3. Subjects under evaluation for potential surgical intervention of anterior cervical discectomy and fusion as established by a board-certified neurosurgeon based on clinical and radiological findings according to good clinical practice.
4. Grade I-III single level sub-axial (C3-C7) cervical spinal canal stenosis (Kang, AJR 2011) on a preliminary anatomical MRI.
5. Deficitary or irritative cervical spinal cord symptoms and/or signs in concordance with MRI findings.

Exclusion Criteria:

1. Subjects unable o.r unwilling to give informed consent .
2. Age \<18 or \> 80
3. Subjects with pacemaker or any other contraindication to undergo high-field (3 Tesla) MRI exam.
4. Pregnancy or planned pregnancy before the end of the study .
5. Co-existing or prior neurological disease of the brain, SC, or peripheral nervous system.
6. Co-existing or prior oncologic disease .
7. Prior surgery in the brain or spine.

Outcomes:
Novel qMRI protocol clinically for the identification and quantification of microstructural Spinal Cord damage