Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy

• Conditions: Cervical Spondylotic Myelopathy
• Interventions: Other: MRI

• Registration Number: NCT04955041
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Utilization of T2\* MRI in predicting prognosis in patients with cervical spondylotic myelopathy (CSM)

Detailed Description

Cervical spondylotic myelopathy (CSM), an age-related degenerative disease that is common worldwide, is mainly caused by compression of the spinal cord and may possibly lead to disability. Surgery to reduce direct compression of the spinal cord might alleviate disease progression; due to individual differences, some patients do not benefit from surgery. Prognostic prediction is important because it affects subsequent treatment decision making. Currently, prognosis is generally based on magnetic resonance imaging (MRI) with a detailed macrostructural evaluation of the spinal cord. Unfortunately, the use of conventional MRI indicators (e.g., increased intensity signal \[ISI\]) to predict CSM outcomes has been controversial because of their subjectivity or the insufficient information contained therein.

A new biomarker, T2\* MRI gray matter to white matter signal intensity ratio (GM/WM), is associated with demyelination and gliosis. Previous studies have shown that patients with CSM can have T2\* MRI WM / GM changes at the early stage of disease, and the WM / GM value is increased, which is significantly higher than that of normal people, and is related to the spinal cord function score. However, the correlation between this index and long-term prognosis remains to be studied.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2020-07
• Primary Completion: 2020-07
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• diagnosed with CSM and operated on by one senior orthopedist
• available preoperative MRI results
• high-quality image data with no motion artifacts
• available preoperative and long-term follow-up (≥1 years) mJOA score

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Exclusion Criteria

• prior head or neck surgery
• a history of notable additional diseases (spinal cord tumor, multiple sclerosis, syringomyelia, spinal cord injury, or motor neuron disease).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
severe CSM	MRI	preoperative mJOA score ≤12
mild CSM	MRI	preoperative modified Japanese Orthopedic Association (mJOA) score ≥15
moderate CSM	MRI	preoperative mJOA score 13\~14

Primary Outcome Measures

Name	Time	Method
Improvement of neurologic function	at follow-up time (≥1 years)	Postoperative modified Japanese Orthopaedic Association (mJOA) at follow-up time