Assessing spinal cord damage in cervical myelopathy using advanced MRI techniques

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

This study is testing a new MRI method to see if it can help find and measure spinal cord damage in people with cervical myelopathy to improve diagnosis and treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Istituto Clinico Humanitas (Academic / other)
• Locations: 1 site (Rozzano)
• Trial ID: NCT06486038 on ClinicalTrials.gov

What this trial studies

This study aims to detect microstructural degeneration in the spinal cord of patients with cervical myelopathy using quantitative MRI (qMRI) techniques. It will compare clinical, biometric, neurophysiological, and imaging data to validate a novel qMRI protocol for identifying and quantifying spinal cord damage. The goal is to create an integrated diagnostic tool for early diagnosis and monitoring of myelopathy, which could help in determining optimal treatment strategies and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with symptoms of cervical spinal cord dysfunction and evidence of cervical spinal canal stenosis.

Not a fit: Patients with prior neurological or oncological diseases, or those unable to undergo MRI, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and better treatment strategies for patients with cervical myelopathy, potentially preventing irreversible damage.

How similar studies have performed: While the approach of using quantitative MRI for spinal cord assessment is innovative, similar studies have shown promise in improving diagnostic accuracy in other conditions.

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.

Where this trial is running

Rozzano

• IRCCS Istituto Clinico Humanitas — Rozzano, Italy (Recruiting)

Study contacts

• Principal investigator: Letterio S POLITI, MD — Humanitas Research Hospital IRCCS, Rozzano-Milan
• Study coordinator: Letterio S POLITI, MD

Conditions Cervical Myelopathy