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

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 Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Spine Injury
• Intervention / Treatment: Procedure: Insertion of Intraspinal pressure monitor

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Perry Dhaliwal, MD MPH; Phone Number: 2047877227; Email: pdhaliwal@exchange.hsc.mb.ca
• Study Contact Backup: Name: Frederick Zeiler, MD PhD; Phone Number: 2047877227; Email: frederick.zeiler@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A1R9
      • Recruiting
      • Health Sciences Centre
      • Contact: Perry Dhaliwal, MD MPH; Phone Number: 2047877227; Email: pdhaliwal@exchange.hsc.mb.ca
      • Contact: Frederick Zeiler, MD PhD; Phone Number: 2047877227; Email: frederick.zeiler@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intraspinal Pressure Monitoring; A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data	Derivation of parameters for optimal spinal cord perfusion pressure.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the accuracy of probe placement in relation to the site of injury		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.		1 year
Record rates of adverse events in patients having insertion of intraspinal pressure monitor	Measure infection rates, rates of pseudomeningoceles, neurological injury, probe dislodgment, meningitis and or subdural hematoma at injury site.	1 year

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Health Sciences Centre Foundation, Manitoba

Publications and helpful links

General Publications

• Dhaliwal P, Wilkinson M, Zeiler FA. The Winnipeg Intraspinal Pressure Monitoring Study (WISP): A protocol for validation of fiberoptic pressure monitoring for acute traumatic spinal cord injury. PLoS One. 2022 Sep 20;17(9):e0263499. doi: 10.1371/journal.pone.0263499. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: spinal cord injury; spinal cord perfusion pressure; intraspinal pressure; spinal reactivity
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Back Injuries; Wounds and Injuries; Spinal Cord Injuries; Spinal Injuries
• Other Study ID Numbers: HS23117 9B2019:075)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No