Spinal Cord InjuriesNCT04550117
Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study
A study testing Insertion of Intraspinal pressure monitor in people with Spinal Cord Injuries and Spine Injury, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Spine Injury
- What is being tested?
- Insertion of Intraspinal pressure monitor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 23 Jun 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • patients with acute traumatic spinal cord injury ASIA A, B or C
- age between 18-70yrs
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Health Sciences Centre
Winnipeg, Manitoba, R3A1R9
Perry Dhaliwal, MD MPH, 2047877227, pdhaliwal@exchange.hsc.mb.ca
Frederick Zeiler, MD PhD, 2047877227, frederick.zeiler@umanitoba.ca
About this 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.
- Conditions
- Spinal Cord Injuries, Spine Injury
- Being tested
- Insertion of Intraspinal pressure monitor
- Keywords
- spinal cord perfusion pressure, spinal cord injury, intraspinal pressure, spinal reactivity
- Medical subject headings
- Spinal Cord Injuries, Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of Intraspinal pressure monitorProcedure or surgery
A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury
| Study group | Role | What they receive |
|---|---|---|
| Intraspinal Pressure Monitoring | Experimental | A fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury Receives: Procedure: Insertion of Intraspinal pressure monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
Derivation of parameters for optimal spinal cord perfusion pressure.
Measured: 1 year
Secondary outcomes (3)
Measurement of the accuracy of probe placement in relation to the site of injury
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start23 Jun 2020
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Responsible party
- Principal investigator, Perry Dhaliwal, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550117
- Sponsor's protocol ID
- HS23117 9B2019:075)
- Status last verified
- Dec 2023
- First submitted
- 24 Jun 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36126069
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study
- ClinicalTrials.gov ID
- NCT04550117
- Acronym / sponsor ID
- HS23117 9B2019:075)
- Conditions
- Spinal Cord Injuries, Spine Injury
- Keywords
- spinal cord perfusion pressure, spinal cord injury, intraspinal pressure, spinal reactivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraspinal Pressure Monitoring | Experimental | Procedure: Insertion of Intraspinal pressure monitorA fiberoptic pressure monitoring device will be placed into the subarachnoid space at the site of traumatic spinal cord injury |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • patients with acute traumatic spinal cord injury ASIA A, B or C
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion of Intraspinal pressure monitorA fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury | Procedure or surgery | Intraspinal Pressure Monitoring |
Primary outcome
Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data
Time frame: 1 year
Derivation of parameters for optimal spinal cord perfusion pressure.
3 secondary outcomes
Measurement of the accuracy of probe placement in relation to the site of injury
Time frame: 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.
Time frame: 1 year
Record rates of adverse events in patients having insertion of intraspinal pressure monitor
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 36126069Dhaliwal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertion of Intraspinal pressure monitor in people with Spinal Cord Injuries and Spine Injury, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perry Dhaliwal, MD MPH (2047877227, pdhaliwal@exchange.hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Derivation of parameters for optimal spinal cord perfusion pressure using intraspinal pressure data (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04550117, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.