Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT04550117

Conditions

Spinal Cord Injuries

Spine Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Insertion of Intraspinal pressure monitor

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Spine Injury

Study ID

NCT04550117

Start date

Jun 23, 2020

Status verified date

Dec, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intraspinal Pressure Monitoring

A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Health Sciences Centre

Recruiting

Winnipeg, Manitoba, Canada, R3A1R9

Contacts

More Information

Sponsor

University of Manitoba

Last update posted

May 29, 2024

Last verified

Dec, 2023

Keywords

  • spinal cord perfusion pressure
  • spinal cord injury
  • intraspinal pressure
  • spinal reactivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2024-05-29.