Actively Recruiting
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
Eligibility Criteria
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
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
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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