A fMRI Study of Compressive Spinal Cord

Neurologic Disorder Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504254
• Other study ID #: UW12-468
• Status: Completed
• Start date: January 11, 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Musculoskeletal Diseases
• Nervous System Diseases
• Neurologic Disorder
• Orthopedic Disorder of Spine
• Spinal Diseases

Intervention

Diagnostic Test:
• MRI examination
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).

Locations

Country	Name	City	State
Hong Kong	The university of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DTI indics	The mean diffusivities and fractional anisotropy will be measured in the DTI	Change between Enrollment and one year after surgery.
Secondary	fMRI connextivity	Functional connectivity will be examined by calculating the averaged correlation coefficient of all regions of interest (ROIs) in gray matters.	Change between Enrollment and one year after surgery.