Prognostic Value of DTI and fMRI of Cervical Myelopathy

NCT03695848 | Completed DMC FDA Device

• 1 other identifier: UW 18-394
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Cervical myelopathy (CM) is one of the most common degenerative spinal cord disorders affecting older people. The progression of CM is insidious and the neurological decline can vary between patients. Surgical decompression is considered the most effective way to treat CM, however, it is not free from risk and the surgical outcome is not always satisfactory. The expected outcome of surgical intervention for CM remains a difficulty. There is a pressing need for a reliable and quantitative approach to predict surgical outcomes of CM and the precise prognosis. Previous studies have suggested a number of prognostic factors, such as age, duration of symptoms, pre-operative neurological status and abnormal MRI, but their prognostic value remains controversial. Recently, diffusion tensor imaging (DTI) and fMRI have been proposed as a promising tool for predicting the surgical prognosis of CM. In previous study, the protocol was successfully established for DTI microstructural characterization and resting state fMRI of the cervical spinal cord. This study is to evaluate the value of DTI and fMRI in predicting the outcome of surgical treatment. The ultimate goal is to establish a clinical protocol for quantitative DTI and fMRI analysis that could give accurate prognosis for surgical intervention to CM.

Conditions

Cervical Myelopathy

Keywords

Cervical Myelopathy，Prognostication，Diffusion Tensor Imaging, fMRI

Outcome Measures

Primary Outcomes (1)

• postoperative neurological improvement rate

  comparison of clinical spinal cord functional changes between pre- and post-operative status.

  Baseline on enrollment and 12 months follow-up

Interventions

MRI scan DEVICE

Before decompresssion surgery, DTI and fMRI will be recorded by a FDA approved 3T MRI scanner (Philips Achieva)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with cervical myelopathy requiring surgical decompression will be recruited.

You may not qualify if:

• Patients with acute spinal cord injuries, prior spinal intervention, with shrapnel or other metal or electronic implants in their bodies (such as pacemakers, aneurysm clips, surgical devices, metallic tattoos on the head, etc.), with claustrophobia and pregnant women will be excluded.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

G Li

Hong Kong, Hong Kong

Location

The university of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: September 26, 2018
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 11, 2023

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)