Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06486038

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

Led by Istituto Clinico Humanitas · Updated on 2024-07-10

100

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

Sponsors

I

Istituto Clinico Humanitas

Lead Sponsor

M

Mediolanum Cardio Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to give informed consent
  • Age between 18 and 80 years
  • Under evaluation for possible anterior cervical discectomy and fusion surgery based on clinical and radiological findings
  • Grade I-III single level sub-axial cervical spinal canal stenosis (C3-C7) on MRI
  • Cervical spinal cord symptoms or signs matching MRI findings
Not Eligible

You will not qualify if you...

  • Unable or unwilling to give informed consent
  • Age younger than 18 or older than 80 years
  • Presence of pacemaker or any contraindication to undergo 3 Tesla MRI
  • Pregnancy or planned pregnancy before study end
  • Co-existing or prior neurological disease of brain, spinal cord, or peripheral nerves
  • Co-existing or prior cancer
  • Prior brain or spinal surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Istituto Clinico Humanitas

Rozzano, Italy, 20089

Actively Recruiting

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Research Team

L

Letterio S POLITI, MD

CONTACT

L

Luca A CAPPELLINI, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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