Effectiveness of T2* MRI in Cervical Spondylotic Myelopathy

Cervical Spondylotic Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04955041
• Other study ID #: M2020317
• Status: Active, not recruiting
• Start date: January 2010
• Est. completion date: June 2022

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 2022
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Spondylotic Myelopathy
• Spinal Cord Diseases

Intervention

Other:
• MRI
T2* MRI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of neurologic function	Postoperative modified Japanese Orthopaedic Association (mJOA) at follow-up time	at follow-up time (=1 years)