Intraspinal Pressure Monitoring for Spinal Cord Injury

Overseen By Frederick Zeiler, MD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Central cord syndrome, Cognitive impairment, Neurodegenerative disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During ICU stay

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for monitoring pressure inside the spine after a traumatic spinal cord injury. Researchers aim to determine if a small device, called an Intraspinal Pressure Monitoring Device, can provide better insights into spinal blood flow. This understanding could improve recovery and function for individuals with spinal cord injuries. The trial seeks participants who have recently experienced a traumatic spinal cord injury and fall under specific injury categories (ASIA A, B, or C, which classify spinal cord injury severity). As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future spinal cord injury treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for spinal cord injury patients?

Research has shown that monitoring pressure inside the spine is generally safe for people with spinal cord injuries. One study found that placing a pressure sensor in the spine can be done accurately and remains safe for up to one week after the injury. This indicates the device typically does not cause harm during use. No major side effects were reported, suggesting it is well-tolerated. Overall, evidence supports the safety of this monitoring method for individuals with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intraspinal pressure monitoring for spinal cord injuries because it offers a new way to directly measure and manage pressure at the injury site. Unlike standard treatments that focus on stabilizing the spine or reducing inflammation, this method involves placing a fiberoptic pressure monitor directly in the subarachnoid space, providing real-time data on pressure changes. This direct monitoring could lead to more precise interventions, potentially improving recovery outcomes and reducing long-term damage. By offering insights that other treatments can't provide, this technique could transform how spinal cord injuries are managed.

What evidence suggests that this technique is effective for spinal cord injury?

Research has shown that monitoring pressure inside the spine can help predict recovery after a spinal cord injury. In this trial, participants will receive an Intraspinal Pressure Monitoring device, which measures both this pressure and the blood flow pressure in the spinal cord, potentially indicating outcomes for nerve function. This allows doctors to better understand how the spinal cord is healing. Early findings suggest this technique could enhance care by providing crucial information about spinal cord health. Although more research is needed, initial results are promising for improving treatment decisions in spinal cord injuries. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-70 who have recently suffered a traumatic spinal cord injury classified as ASIA A, B, or C. It's not specified who can't join the trial.

Inclusion Criteria

My spinal cord injury is classified as severe to moderate (ASIA A, B, or C).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

During ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and functional outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Insertion of Intraspinal pressure monitor

Trial Overview The study tests inserting a fiberoptic pressure monitor into the spine to measure pressure and blood flow after an injury. The goal is to find optimal conditions for spinal health during ICU recovery.

How Is the Trial Designed?

Group I: Intraspinal Pressure Monitoring Experimental Treatment 1 Intervention

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

Insertion of Intraspinal pressure monitor is already approved in European Union, United States for the following indications:

Approved in European Union as Intraspinal Pressure Monitoring Device for:

• Acute Traumatic Spinal Cord Injury

Approved in United States as Intraspinal Pressure Monitoring Device for:

• Acute Traumatic Spinal Cord Injury

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Health Sciences Centre Foundation, Manitoba

Collaborator

Trials

17

Recruited

9,500+

Published Research Related to This Trial

A new technique for safely monitoring intraspinal pressure at the injury site in 18 patients with severe traumatic spinal cord injury showed that intraspinal pressure was significantly higher than in control subjects without injury, indicating a potential area for therapeutic intervention.

Increasing spinal cord perfusion pressure through inotropic support improved motor-evoked potentials in all patients studied, suggesting that managing perfusion pressure could enhance spinal cord function after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring of spinal cord perfusion pressure in acute spinal cord injury: initial findings of the injured spinal cord pressure evaluation study*. Werndle, MC., Saadoun, S., Phang, I., et al.[2019]

A novel technique for monitoring intraspinal pressure (ISP) in 14 patients with severe traumatic spinal cord injury (TSCI) was found to be feasible and safe, allowing for monitoring up to a week after injury without complications.

The ISP signal characteristics observed were similar to those of intracranial pressure (ICP) after traumatic brain injury, suggesting that ISP monitoring could provide valuable insights into spinal cord injuries, although further studies are needed to assess its impact on neurological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of Intraspinal Pressure After Spinal Cord Injury: Technical Note from the Injured Spinal Cord Pressure Evaluation Study. Werndle, MC., Saadoun, S., Phang, I., et al.[2017]

The new No. 4 French fiberoptic catheter for intracranial pressure (ICP) monitoring has been shown to be safe and reliable in both animal studies and clinical trials involving 20 patients (15 adults and 5 pediatric).

This device has been successfully used in a large number of patients without significant complications, although occasional breakage of the optic fiber has occurred, which can be easily fixed by replacing the probe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous monitoring of intracranial pressure with a miniaturized fiberoptic device. Ostrup, RC., Luerssen, TG., Marshall, LF., et al.[2008]

In a study of 101 fiberoptic pressure transducers used in 86 patients, only four minor complications occurred, indicating a high safety profile for these devices during monitoring.

The study found significant zero drift in pressure readings from the transducers, suggesting that these readings should not be solely relied upon for clinical decisions without considering other clinical and radiological data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective study of zero drift in fiberoptic pressure monitors used in clinical practice. Bavetta, S., Norris, JS., Wyatt, M., et al.[2008]

This study successfully implemented a strain gauge pressure monitor to measure intraspinal pressure in a patient with acute traumatic spinal cord injury, allowing for the calculation of spinal cord perfusion pressure without complications.

The patient, who had lost motor and sensory function in the lower extremities due to a T12 burst fracture, showed some recovery after surgery and rehabilitation, highlighting the potential benefits of monitoring spinal cord perfusion pressure in managing such injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: Continuous spinal cord physiologic monitoring following traumatic spinal cord injury-A report from the Winnipeg Intraspinal Pressure Study (WISP). Dhaliwal, P., Gomez, A., Zeiler, FA.[2023]

In a study of 140 patients monitored with a fiberoptic intracranial pressure (ICP) monitor, 80 had increased ICP, with 100% of patients suffering from nontraumatic intracerebral hematoma and subarachnoid hemorrhage showing elevated pressure.

The fiberoptic ICP monitoring system proved effective in guiding treatment decisions for patients with head injuries and hemorrhages, demonstrating its reliability and safety, yet it is not routinely used due to acceptance issues in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a fiberoptic intracranial pressure monitor in clinical practice. Levin, AB.[2019]

In a study of 46 head-injured patients monitored for up to 32 days using a fiberoptic intracranial pressure monitoring system, there were no reported infections, highlighting the safety of the method.

Out of the patients monitored, 33 had elevated intracranial pressure, with 16 requiring treatment, indicating that this monitoring can effectively identify patients needing intervention and may also assist in determining patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a fiberoptic intracranial pressure transducer in the treatment of head injuries. Levin, AB.[2019]

Intraspinal pressure monitoring using a pressure probe is accurate and safe for up to a week in patients with severe traumatic spinal cord injuries, with only minor complications observed in 10% of patients.

The study found that patient positioning affects intraspinal pressure, with higher pressures recorded in the supine position after laminectomy, suggesting that this position should be avoided to prevent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile and probe placement accuracy of intraspinal pressure monitoring for traumatic spinal cord injury: Injured Spinal Cord Pressure Evaluation study. Phang, I., Zoumprouli, A., Saadoun, S., et al.[2019]

The Winnipeg Intraspinal Pressure Monitoring Study (WISP) aims to validate intraspinal pressure monitoring techniques in 20 patients with acute traumatic spinal cord injury, measuring key physiological parameters over a 12-month follow-up period.

This study represents the first effort in North America to use fiberoptic pressure monitoring at the injury site, which could lead to improved understanding of spinal cord perfusion and better management of secondary injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Winnipeg Intraspinal Pressure Monitoring Study (WISP): A protocol for validation of fiberoptic pressure monitoring for acute traumatic spinal cord injury. Dhaliwal, P., Wilkinson, M., Zeiler, FA.[2022]

Citations

1. trialx.com trialx.com/clinical-trials/listings/275155/intraspinal-pressure-monitoring-for-acute-traumatic-spinal-cord-injury-a-validation-study/

Intraspinal Pressure Monitoring for Acute Traumatic Spinal ... The primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36126069/

The Winnipeg Intraspinal Pressure Monitoring Study (WISP) The WISP study is a single center pilot study designed to validate the technique of intraspinal pressure monitoring following acute traumatic spinal cord ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772529424011755

The concepts of Intra Spinal Pressure (ISP ... Intraspinal pressure and spinal cord perfusion pressure predict neurological outcome after traumatic spinal cord injury.

4. link.springer.com link.springer.com/article/10.1007/s00701-024-06283-9

Invasive devices to monitor the intraspinal perfusion ... Data extracted included number of patients included, severity of injury, characteristics of the intervention—intrathecal device used to record ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02721615

NCT02721615 | Injured Spinal Cord Pressure Evaluation This is a pilot study to find out whether spinal cord pressure and metabolism can be measured after spinal cord injury and whether they are effected by ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27129044/

Injured Spinal Cord Pressure Evaluation study After traumatic spinal cord injury intradural placement of the pressure probe is accurate and intraspinal pressure monitoring is safe for up to a week.

7. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/25/3/article-p398.xml

Injured Spinal Cord Pressure Evaluation study in: Journal of ... These data suggest that after traumatic spinal cord injury intradural placement of the pressure probe is accurate and intraspinal pressure ...