Clinical trial NCT03504254: A fMRI Study of Compressive Spinal Cord
Official title: Plasticity of Chronically Compressive Spinal Cord After Surgical Decompression - A fMRI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder of Spine
Neurologic Disorder
Keywords: cervical spondylotic myelopathy
diffusion tensor imaging
functional magnetic resonance imaging
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 50 CM patients requiring surgical decompression will be recruited.

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.

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.

Eligibility 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.

Primary outcomes:
measure: DTI indics
timeFrame: Change between Enrollment and one year after surgery.
Secondary outcomes:
measure: fMRI connextivity
timeFrame: Change between Enrollment and one year after surgery.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The university of Hong Kong
Study officials:
References: