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Trial record 16 of 365 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Diseases"

A fMRI Study of Compressive Spinal Cord (CSM Plasticity)

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ClinicalTrials.gov Identifier: NCT03504254
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment
Orthopedic Disorder of Spine Neurologic Disorder Diagnostic Test: MRI examination

Detailed 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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasticity of Chronically Compressive Spinal Cord After Surgical Decompression - A fMRI Study
Actual Study Start Date : January 11, 2012
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Group/Cohort Intervention/treatment
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
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 50 CM patients requiring surgical decompression will be recruited.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504254


Contacts
Contact: Guangsheng Li, Master 852-29740336

Locations
Hong Kong
The university of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Guangsheng Li    852-29740336      
Sponsors and Collaborators
The University of Hong Kong

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03504254     History of Changes
Other Study ID Numbers: UW12-468
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No

Keywords provided by The University of Hong Kong:
cervical spondylotic myelopathy
diffusion tensor imaging
functional magnetic resonance imaging

Additional relevant MeSH terms:
Disease
Musculoskeletal Diseases
Nervous System Diseases
Spinal Diseases
Pathologic Processes
Bone Diseases