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Search / Trial NCT06486038

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

Launched by ISTITUTO CLINICO HUMANITAS · Jun 26, 2024

Trial Information

Current as of May 13, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to use MRI (a type of imaging that creates detailed pictures of the inside of the body) to detect early signs of spinal cord damage in patients with cervical myelopathy, a condition that affects the neck and can cause various symptoms like pain, weakness, or numbness. The goal is to identify patients who may need surgery before their condition worsens and to help those who might not need surgery avoid unnecessary procedures. Researchers will compare MRI results with other clinical tests to create a better tool for diagnosing and monitoring this condition.

To participate, individuals must be between 18 and 80 years old and have specific neck issues confirmed by a doctor, such as narrowing of the spinal canal and related symptoms. Participants will undergo several assessments, including MRIs and clinical evaluations, at different points over six months. This study aims to improve how we understand and treat cervical myelopathy, helping doctors make more informed decisions about patient care. If you're interested, it's important to know that certain health conditions or previous surgeries may prevent participation, so discussing eligibility with your healthcare provider is essential.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Subjects willing and able to give informed consent for participation in the study.
  • 2. Age 18-80.
  • 3. 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.
  • 4. Grade I-III single level sub-axial (C3-C7) cervical spinal canal stenosis (Kang, AJR 2011) on a preliminary anatomical MRI.
  • 5. Deficitary or irritative cervical spinal cord symptoms and/or signs in concordance with MRI findings.
  • Exclusion Criteria:
  • 1. Subjects unable o.r unwilling to give informed consent .
  • 2. Age \<18 or \> 80
  • 3. Subjects with pacemaker or any other contraindication to undergo high-field (3 Tesla) MRI exam.
  • 4. Pregnancy or planned pregnancy before the end of the study .
  • 5. Co-existing or prior neurological disease of the brain, SC, or peripheral nervous system.
  • 6. Co-existing or prior oncologic disease .
  • 7. Prior surgery in the brain or spine.

About Istituto Clinico Humanitas

Istituto Clinico Humanitas is a leading clinical research organization based in Italy, dedicated to advancing medical science through innovative clinical trials and research initiatives. With a strong emphasis on patient-centered care and cutting-edge methodologies, the institute collaborates with various stakeholders in the healthcare sector to develop and evaluate new therapies and treatment protocols. Its multidisciplinary team of experts is committed to ensuring the highest standards of ethical practice and scientific rigor, contributing to significant advancements in medical knowledge and improved patient outcomes.

Locations

Rozzano, , Italy

Patients applied

0 patients applied

Trial Officials

Letterio S POLITI, MD

Principal Investigator

IRCCS Istituto Clinico Humanitas

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported