A fMRI Study of Compressive Spinal Cord

NCT03504254 | Completed DMC FDA Device

• 1 other identifier: UW12-468
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical myelopathy (CM), a chronically compressive spinal cord lesion, is the most common cause of non-traumatic paraparesis/quadriparesis among the elderly. Hong Kong is facing a heavy social economic burden from CM with the rapidly aging population. Surgical decompression is considered as the mainstay of the treatment for CM patients to relieve their symptoms and signs. Yet the surgical outcome is not always satisfactory. There is a pressing need for understanding the exact mechanism of surgical decompression on the recovery of myelopathic cord in order to improve the prognosis of CM patients in near future.This project will evaluate neuronal activities and axon regeneration by longitudinally monitoring at time zero, 3 and 6 month after the surgery in CM patients using UTE, BOLD-fMRI and DTI, and to investigate the relationship of preoperative neuronal activities of myelopathic cord with axon regeneration.

Conditions

Orthopedic Disorder of Spine; Neurologic Disorder

Keywords

cervical spondylotic myelopathy; diffusion tensor imaging; functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• DTI indics

  The mean diffusivities and fractional anisotropy will be measured in the DTI

  Change between Enrollment and one year after surgery.

Secondary Outcomes (1)

• fMRI connextivity

  Change between Enrollment and one year after surgery.

Study Arms (1)

CSM

A total of 50 CM patients requiring surgical decompression will be recruited. The inclusion criteria are a clinical diagnosis of CM including the signs of corticospinal lesions together with the appropriate radiographic findings. Patients with acute spinal cord injuries, prior spinal intervention or claustrophobia will be excluded.

Diagnostic Test: MRI examination

Interventions

MRI examination DIAGNOSTIC_TEST

Three kinds of MRI techniques will be used in this study. These are (1) axial T1-weighted (T1WI) and T2-weighted imaging (T2WI), UTE MRI, (2) BOLD-based fMRI, and (3) diffusion tensor imaging (DTI).

CSM

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 50 CM patients requiring surgical decompression will be recruited.

You may not qualify if:

• Patients with acute spinal cord injuries, prior spinal intervention or claustrophobia will be excluded.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The university of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Design

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

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: April 20, 2018
• Study Start: January 11, 2012
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: May 10, 2023

Record last verified: 2019-09

Locations

HK (1)