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Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy

P

Peking University

Status

Unknown

Conditions

Cervical Spondylotic Myelopathy

Treatments

Other: MRI

Study type

Observational

Funder types

Other

Identifiers

NCT04955041
M2020317

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

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).

Trial design

200 participants in 3 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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