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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Insertion of Intraspinal pressure monitor, Intraspinal Pressure Monitoring Device, Fiberoptic Pressure Monitoring Device for spinal cord injury?

The research shows that intraspinal pressure monitoring is safe and accurate for patients with spinal cord injuries, with some patients showing improvement in their condition over time. Additionally, similar fiberoptic pressure monitoring techniques have been effectively used in treating head injuries by helping guide therapy decisions. ^{1 2 3 4 5}

Is intraspinal pressure monitoring safe for humans?

Intraspinal pressure monitoring has been shown to be generally safe in humans with traumatic spinal cord injuries, with minor complications like probe displacement and cerebrospinal fluid leakage occurring in a small number of cases. No serious complications such as infections or neurological deterioration were reported in the studies. ^{1 2 6 7 8}

How is intraspinal pressure monitoring different from other treatments for spinal cord injury?

Intraspinal pressure monitoring is unique because it involves inserting a pressure probe directly at the injury site to continuously measure the pressure within the spinal cord, similar to how brain pressure is monitored after a brain injury. This approach is novel as it provides real-time data on spinal cord pressure, which can help guide treatment decisions to potentially improve outcomes after a spinal cord injury. ^{1 2 5 8 9}

Eligibility Criteria

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).

I am between 18 and 70 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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*. [2019]

2. United States 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Continuous monitoring of intracranial pressure with a miniaturized fiberoptic device. [2008]

7. United States pubmed.ncbi.nlm.nih.gov

Prospective study of zero drift in fiberoptic pressure monitors used in clinical practice. [2008]

8. Austria pubmed.ncbi.nlm.nih.gov

Measurement of Intraspinal Pressure After Spinal Cord Injury: Technical Note from the Injured Spinal Cord Pressure Evaluation Study. [2017]

9. Switzerland 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). [2023]