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

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.

Conditions

• Cervical Myelopathy

Interventions

DIAGNOSTIC_TEST

MRI standard and qMRI

Non-contrast cervical spine MRI including morphological and quantitative MRI sequences on a 3 Tesla scanner. MRI examination includes conventional and experimental sequences

OTHER

MEPs and SSEPs

Neurophysiological examination by motor and somatosensorial evocked potential using transcranial magnetic stimulation and electrical stimulation to the peripheral nerve

OTHER

Neuromotor assessment

Upper and Lower limb assessment: Purdue Pegboard Test (PTT), Box and Block test (BBT), Nine Hole Peg Test (NHPT), gait analysis and 30 seconds sit to stand test (30CST)

PROCEDURE

Anterior cervical discectomy and fusion

If applicable: Anterior cervical discectomy and fusion surgery using PEEK or modern carbon fiber material

Sponsors & Collaborators

• Mediolanum Cardio Research

  collaborator OTHER

• Istituto Clinico Humanitas

  lead OTHER

Principal Investigators

• Letterio S POLITI, MD · IRCCS Istituto Clinico Humanitas

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-03

Primary Completion

2025-05-31

Completion

2025-05-31

Countries

• Italy

Study Locations