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NCT Number: NCT03504254

A fMRI Study of Compressive Spinal Cord

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.

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Key information

Conditions

Orthopedic Disorder of Spine Nervous System Diseases Neurologic Disorder

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The university of Hong Kong

Hong Kong

About this study

This study aims to monitor the structural and functional changes of chronically compressed spinal cords longitudinally after surgical decompression in vivo. 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). To quantitatively investigate the structural deficits, T1/T2 MRIs will delineate the gross morphology of the spinal cord, CSF, and surrounding anatomical structures, while DTI will quantify the fiber orientation and integrity within the spinal cord. BOLD-based functional MRIs will assess the local hemodynamic changes and neuron activities in response to the motor or sensory stimulation along the C3 to C8 spinal nerve levels. The MRI evaluations will be applied to the same cervical myelopathy (CM) patient before surgery and 3 and 6 months post-surgery, when clinical recovery reaches a plateau9. Clinical examination will include neurological evaluation, Japanese Orthopaedic Association (JOA) scoring assessment, and clinical electrophysiological evaluation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The inclusion criteria are a clinical diagnosis of CM including the signs of corticospinal lesion/s together with the appropriate radiographic findings.

Exclusion criteria

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

Treatment and study plan

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).

Primary outcomes

  1. DTI indics

    Time frame: Change between Enrollment and one year after surgery.

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

Secondary outcomes

  1. fMRI connextivity

    Time frame: Change between Enrollment and one year after surgery.

    Functional connectivity will be examined by calculating the averaged correlation coefficient of all regions of interest (ROIs) in gray matters.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Plasticity of Chronically Compressive Spinal Cord After Surgical Decompression - A fMRI Study

Acronym: CSM Plasticity

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2018
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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