Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study

Overview

Intraspinal pressure monitoring has been advanced as a potential technique for evaluating spinal cord perfusion after traumatic spinal cord injury. In this study, the investigators aim to validate the technique for insertion of a fiberoptic pressure monitoring device in the subarachnoid space at the site of injury for measurement of intraspinal pressure and spinal cord perfusion pressure. The primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal spinal cord perfusion pressure, spinal cord reserve capacity and spinal reactivity index using data obtained during the patient's stay in the intensive care unit.

Secondary objectives of this study will be to a) evaluate the safety of invasive intraspinal pressure monitoring, b) prospectively evaluate the overall relationship between spinal cord perfusion pressure and functional outcomes in patients with acute traumatic spinal cord injury and c) evaluate the relationship between spinal cord perfusion pressure, motor evoked potentials and functional outcomes after incomplete spinal cord injury.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2022

Interventions

  • Procedure: Insertion of Intraspinal pressure monitor
    • A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury

Arms, Groups and Cohorts

  • Experimental: Intraspinal Pressure Monitoring
    • A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury

Clinical Trial Outcome Measures

Primary Measures

  • Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
    • Time Frame: 1 year
    • Derivation of parameters for optimal spinal cord perfusion pressure.

Secondary Measures

  • Measurement of the accuracy of probe placement in relation to the site of injury
    • Time Frame: 1 year
  • Measure the correlation between spinal cord perfusion pressure and the American Spinal Injury Association (ASIA) Impairment scale, Quality of Life Index and Spinal Cord Independence Measure score.
    • Time Frame: 1 year
  • Record rates of adverse events in patients having insertion of intraspinal pressure monitor
    • Time Frame: 1 year
    • Measure infection rates, rates of pseudomeningoceles, neurological injury, probe dislodgment, meningitis and or subdural hematoma at injury site.

Participating in This Clinical Trial

Inclusion Criteria

  • • patients with acute traumatic spinal cord injury ASIA A, B or C
  • age between 18-70yrs

Exclusion Criteria

  • patients with central cord syndrome
  • patients presenting to hospital >48hrs from time of spinal cord injury
  • patients unable to communicate in english language
  • pre-existing cognitive impairment
  • penetrating spinal cord injury
  • pre-existing neurodegenerative disorder involving brain or spinal cord
  • patients with concomitant injuries requiring emergent surgical intervention

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Manitoba
  • Collaborator
    • Health Sciences Centre Foundation, Manitoba
  • Provider of Information About this Clinical Study
    • Principal Investigator: Perry Dhaliwal, Assistant Professor of Neurosurgery – University of Manitoba

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