Monitoring intraspinal pressure for spinal cord injuries
Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study
This study is testing a new way to measure pressure in the spinal cord of patients with recent spinal cord injuries to see if it can help improve their recovery and ensure the method is safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Manitoba Academic / other |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT04550117 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a technique for monitoring intraspinal pressure in patients with acute traumatic spinal cord injuries. Investigators will insert a fiberoptic pressure monitoring device into the subarachnoid space at the injury site to measure intraspinal pressure and spinal cord perfusion pressure. The primary goal is to establish parameters for optimal spinal cord perfusion and assess the safety of this invasive monitoring method. Additionally, the study will explore the relationship between spinal cord perfusion pressure and functional outcomes in affected patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-70 with acute traumatic spinal cord injury classified as ASIA A, B, or C.
Not a fit: Patients with central cord syndrome, those who present more than 48 hours post-injury, or those with significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of spinal cord injuries, potentially enhancing patient outcomes.
How similar studies have performed: While the approach of intraspinal pressure monitoring is innovative, similar studies have not been widely conducted, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winnipeg, Manitoba
- Health Sciences Centre — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Study coordinator: Perry Dhaliwal, MD MPH
- Email: pdhaliwal@exchange.hsc.mb.ca
- Phone: 2047877227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.