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

NCT06486038 | Recruiting DMC

• 1 other identifier: NEURAD-2022-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Cervical Myelopathy

Outcome Measures

Primary Outcomes (1)

• Novel qMRI protocol clinically for the identification and quantification of microstructural Spinal Cord damage

  A preliminary non-contrast cervical spine MRI including morphological and quantitative sequences on a 3 Tesla scanner: * 2D Sagittal T2-w turbo spin-echo (TSE) * 2D Sagittal T2-w TSE with short tau inversion recovery (STIR) * 3D Sagittal T1-w MP-RAGE with 1x1x1mm3 resolution * 2D Transversal T2\*-w MEDIC gradient echo * 2D Transversal Phase Sensitive Inversion Recovery (PSIR) (0.7x0.7x6.0mm3) * 2D Transversal IR TrueFISP sampling 23 different inversion times (TI-scout, 1.0.1.0x10.0mm3) * 2D Transversal reduced-FOV ZOOM-EPI spin-echo DTI (180x53mm2 FOV, 5 slices, b=800 s/mm2, 21 directions, 5 interspersed b=0s/mm2 volumes, 0.9x0.9x6.0mm3) with pulse trigger PSIR, TI-scout and DTI sequences will be set perpendicularly to the cord. Acquisition of single-slice images at the level of three consecutive intervertebral discs, with the middle one corresponding to the lesion. An image-processing pipeline embedded in a XNAT system will process images.

  from baseline until the second follow up (around 6 months)

Secondary Outcomes (1)

• Integrated diagnostic tool

  from month 3 to month 13

Study Arms (1)

Multidisciplinary and innovative approach

EXPERIMENTAL

MRI examination using experimental sequences on 3 Tesla scanner. Neuromotor assessment by an ad-hoc evaluation of the neuromotor skills that includes upper and lower limb assessment. Neurophysiological Assessment: Motor evoked potential (MEP) and Somatosensory evoked potential (SEP) evaluations. Neurological and clinical data (including mJOA and Barthel Index) Surgery (if applicable) using a cage in Polyetheretherketone (PEEK) or modern carbon fiber material.

Diagnostic Test: MRI standard and qMRI; Other: MEPs and SSEPs; Other: Neuromotor assessment; Procedure: Anterior cervical discectomy and fusion

Interventions

MRI standard and qMRI DIAGNOSTIC_TEST

Non-contrast cervical spine MRI including morphological and quantitative MRI sequences on a 3 Tesla scanner. MRI examination includes conventional and experimental sequences

Multidisciplinary and innovative approach

MEPs and SSEPs OTHER

Neurophysiological examination by motor and somatosensorial evocked potential using transcranial magnetic stimulation and electrical stimulation to the peripheral nerve

Multidisciplinary and innovative approach

Neuromotor assessment OTHER

Upper and Lower limb assessment: Purdue Pegboard Test (PTT), Box and Block test (BBT), Nine Hole Peg Test (NHPT), gait analysis and 30 seconds sit to stand test (30CST)

Multidisciplinary and innovative approach

Anterior cervical discectomy and fusion PROCEDURE

If applicable: Anterior cervical discectomy and fusion surgery using PEEK or modern carbon fiber material

Multidisciplinary and innovative approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Mediolanum Cardio Research: collaborator

Study Sites (1)

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Officials

• Letterio S POLITI, MD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Letterio S POLITI, MD

CONTACT

+390282245644; letterio.politi@hunimed.eu

Luca A CAPPELLINI, MD

CONTACT

luca.cappellini@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: July 3, 2024
• Study Start: April 3, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

IT (1)