Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy

June 29, 2021 updated by: Peking University Third Hospital

Effectiveness of T2* MRI in Predicting Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients came from Peking University Third Hospital

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mild CSM
preoperative modified Japanese Orthopedic Association (mJOA) score ≥15
Other: MRI
T2* MRI
moderate CSM
preoperative mJOA score 13~14
Other: MRI
T2* MRI
severe CSM
preoperative mJOA score ≤12
Other: MRI
T2* MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of neurologic function
Time Frame: at follow-up time (≥1 years)
Postoperative modified Japanese Orthopaedic Association (mJOA) at follow-up time
at follow-up time (≥1 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Huishu Yuan, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

July 1, 2020

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2020317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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