Diffusion MRI in Cervical Spondylotic Myelopathy

Cervical Spondylotic Myelopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04952831
• Other study ID #: M2020408
• Status: Enrolling by invitation
• Start date: September 1, 2020
• Est. completion date: September 1, 2024

Study information

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

Clinical Trial Summary

diffusion MRI in evaluates and predicts prognosis in CSM

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• diffusion MRI (dMRI)
All participants underwent dMRI scan at baseline

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	diagnosis of CSM	whether participants are diagnosed as CSM at baseline.	at baseline