Status:
RECRUITING
Quatitative MRI of the Spinal Cord in Cervical Myelopathy: Assessment of Microstuctural Damage for Outcome Improvement
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Mediolanum Cardio Research
Conditions:
Cervical Myelopathy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 degener...
Detailed Description
Rationale Degenerative cervical myelopathy (DCM) is a common chronic disorder and the most common cause of spinal cord dysfunction in adults, potentially leading to severe functional impairment with h...
Eligibility Criteria
Inclusion
- Subjects willing and able to give informed consent for participation in the study.
- Age 18-80.
- 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.
- Grade I-III single level sub-axial (C3-C7) cervical spinal canal stenosis (Kang, AJR 2011) on a preliminary anatomical MRI.
- Deficitary or irritative cervical spinal cord symptoms and/or signs in concordance with MRI findings.
Exclusion
- Subjects unable o.r unwilling to give informed consent .
- Age \<18 or \> 80
- Subjects with pacemaker or any other contraindication to undergo high-field (3 Tesla) MRI exam.
- Pregnancy or planned pregnancy before the end of the study .
- Co-existing or prior neurological disease of the brain, SC, or peripheral nervous system.
- Co-existing or prior oncologic disease .
- Prior surgery in the brain or spine.
Key Trial Info
Start Date :
April 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06486038
Start Date
April 3 2024
End Date
May 31 2025
Last Update
July 10 2024
Active Locations (1)
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1
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089