Actively Recruiting
Quantitative MRI of the Spinal Cord in Cervical Myelopathy: Assessment of Microstructural Damage for Outcome Improvement
Led by Istituto Clinico Humanitas · Updated on 2024-07-10
100
Participants Needed
1
Research Sites
N/A
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
Researchers are studying cervical degenerative myelopathy (DCM), a common spinal cord disorder causing disability due to chronic compression. This study aims to detect early microstructural spinal cord damage before symptoms worsen or persist after surgery or conservative treatment. It focuses on validating a new quantitative MRI (qMRI) protocol to identify and measure spinal cord damage and to develop an integrated diagnostic tool combining imaging, clinical, neurophysiological, and neuromotor data. Participants will undergo MRI scans at baseline, 1 month, and 6 months using standard and experimental sequences on a 3 Tesla scanner. Neuromotor assessments and neurophysiological tests, including motor and somatosensory evoked potentials, will be performed at similar intervals. If appropriate, participants may receive anterior cervical discectomy and fusion surgery using advanced surgical materials that allow high-quality imaging without distortion. During the study, researchers will collect clinical data, perform detailed movement analysis, and monitor neurological function. The primary outcome is the identification and quantification of spinal cord microstructural damage using the new qMRI protocol over six months. Secondary outcomes include developing an integrated diagnostic tool through artificial intelligence combining all collected data. The study involves regular assessments to track disease progression and treatment effects, aiming to improve early diagnosis and personalized care.
CONDITIONS
Brief 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
- Being evaluated 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) diagnosed by MRI
- Presence of 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
- Having a pacemaker or other contraindications to 3 Tesla MRI
- Pregnant or planning pregnancy before study completion
- Having other neurological diseases of brain, spinal cord, or peripheral nerves
- Having current or past cancer
- Previous brain or spine surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline to 1 month
Participants undergo MRI scans including conventional and advanced quantitative sequences, clinical data collection, neuromotor assessments, and neurophysiological testing to evaluate spinal cord microstructural damage before any treatment.
3 visits (in-person) at baseline, 1 month, and 6 months
Duration - As applicable based on clinical indication
Participants who require surgery undergo anterior cervical discectomy and fusion using advanced PEEK or carbon fiber materials. Non-surgical participants continue standard care.
1 surgical procedure visit (in-person)
Duration - Up to 6 months after baseline
Participants are followed with repeated MRI, clinical, neuromotor, and neurophysiological assessments to monitor recovery and spinal cord changes after surgery or during non-surgical management.
Follow-up visits at 1 month and 6 months (in-person)
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
Research Team
L
Letterio S POLITI, MD
L
Luca A CAPPELLINI, MD
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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