Diffusion MRI in Cervical Spondylotic Myelopathy

Utilization of Diffusion Magnetic Resonance Imaging (dMRI) in Evaluation of Spinal Cord Dysfunction and Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)

diffusion MRI in evaluates and predicts prognosis in CSM

Study Overview

• Status: Enrolling by invitation
• Conditions: Cervical Spondylotic Myelopathy
• Intervention / Treatment: Other: diffusion MRI (dMRI)

Detailed Description

Cervical spondylotic myelopathy (CSM) is a spinal dysfunction disease common in the elderly population caused by cervical spine degeneration, spinal canal stenosis, and spinal cord compression. It may result in reduced quality of life or even disability. With the increased life expectancy of today's population, the incidence of CSM is increasing. Surgery is recommended to reduce compression of the spinal cord. However, due to individual differences and variations in spinal cord injury severity, the prognosis after surgery is often unpredictable. Therefore, proper evaluation of spinal cord function and prognosis prediction are important considerations for the clinical decision of whether to operate and selection of appropriate operation time. To achieve this goal, medical images are used to correctly evaluate the damage and recovery potential of neurons. Magnetic resonance imaging (MRI) provides spinal cord macrostructure details and can detect spinal cord damage. Clinically, conventional MRI is often used to confirm a CSM diagnosis and predict prognosis. However, MRI assessments, including increased signal intensity (ISI) and T1 hypo-intensity, might not be consistent with clinical manifestations or prognostic expectations.

Diffusion MRI (dMRI) enables early diagnoses and prognostic predictions due to its microstructure assessment advantages. The diffusion of water molecules is restricted due to structural barriers, such as axon membranes and myelin sheaths. Using the microscopic movement of water molecules, dMRI can detect microstructures indirectly using a model with specific underlying probability distribution function of diffusion. Three models are widely applied clinically: diffusion tensor imaging (DTI), diffusional kurtosis imaging (DKI), and neurite orientation dispersion and density imaging (NODDI). DTI assumes the diffusion distribution function to be Gaussian, DKI assumes it to be non-Gaussian, and NODDI assumes it to be multi-compartmental (intracellular pool, extracellular pool, and free water). Previous studies suggested the potential application value of DTI and DKI in patients with CSM; however, these models had limited specificity and were not sufficient to diagnose CSM in a clinical setting. Compared with DTI and DKI, NODDI has been shown to characterize spinal cord microstructure better.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 010
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The patients come from the Peking University Third Hospital. Healthy volunteers come from online recruitment.

Description

Inclusion Criteria:

• ages ranged 30-75
• compliance to MRI scan
• no MRI contraindication
• (Patients) clinical diagnosis of CSM and surgery in our hospital
• (Healthy controls) no spinal cord dysfunction

Exclusion Criteria:

• prior head or neck surgery or accompanying diseases with neurologic deficits and/or symptoms including multiple sclerosis, spinal cord injury, motor neuron disease, or spinal cord tumour
• images with motion artifact

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with mild CSM; mJOA score ≥15	Other: diffusion MRI (dMRI); All participants underwent dMRI scan at baseline
Patients with moderate CSM; mJOA score 13~14	Other: diffusion MRI (dMRI); All participants underwent dMRI scan at baseline
Patients with severe CSM; mJOA score ≤ 12	Other: diffusion MRI (dMRI); All participants underwent dMRI scan at baseline
Controls; health volunteers	Other: diffusion MRI (dMRI); All participants underwent dMRI scan at baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative neurologic improvement	Postoperative modified Japanese Orthopaedic Association (mJOA) and recovery rate (RR) at 3-month, 6-month, 12-month, and 24-month for patients	3-month, 6-month, 12-month, and 24-month
diagnosis of CSM	whether participants are diagnosed as CSM at baseline.	at baseline

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Huishu Yuan, Dr, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: M2020408

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No