Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-30
Brief Title:
Crainio Non-invasive ICP Monitor for TBI
Sponsor:
Crainio Ltda
Organization:
Crainio Ltda
Study Overview
Official Title:
Crainio Non-invasive Intracranial Pressure Monitor for Traumatic Brain Injury Product Development
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The clinical investigation aims to advance the Crainio device designed for non-invasive intracranial pressure ICP monitoring This feasibility study involves 54 participants over a 12-month period and seeks to collect cerebral photoplethysmogram signals alongside concurrent invasive ICP measurements in patients with traumatic brain injury The primary objective is to establish the diagnostic accuracy of the Crainio device aiming for at least 90 sensitivity and specificity in detecting raised ICP above 20 mmHg Secondary objectives include evaluating patient-related factors such as skin tone skull thickness and skull density as well as the tolerability and acceptance of the device by both patients and healthcare professionals
Detailed Description:
Intracranial pressure ICP is routinely monitored in patients suffering from traumatic brain injury TBI Raised ICP can result in compression of the cerebral vasculature and subsequent reduction in oxygen and nutrient delivery to the brain leading to significant morbidity and mortality In fact raised ICP is the most common cause of death in patients with severe TBI
Standard ICP monitoring requires insertion of a cranial bolt into the skull through which an electrical transducer is inserted Alternatively an intra-ventricular catheter is inserted through a burr hole Both of these monitoring methods are associated with risks including haemorrhage and infection as well as delay in establishing emergency monitoring and limiting it to hospitals that have neurosurgery
There has been much research in recent years to find a method for measuring intracranial pressure noninvasively nICP including measurement of pressure in the retinal veins measurement of eardrum displacement transcranial Doppler ultrasonography and imaging-based solutions These methods all require considerable user intervention and are non-continuous
This project aims to collect cerebral photoplethysmogram signals and concurrent invasive ICP measurements from patients with traumatic brain injury to develop Crainio machine learning ML algorithms The core intellectual property IP of this continuous external monitoring ICP system was originally developed by academics in the lab of Professor Kyriacou at City University of London Crainio is a spin-out company that was created to industrialise and commercialise this research on an exclusive basis
The device comprises a forehead-mounted sensor containing infrared light sources that can illuminate the deep brain tissue of the frontal lobe Photodetectors in the sensor detect the backscattered light which is modulated by pulsation of the cerebral arteries A control unit processes the backscattered light called the photoplethysmogram PPG and transmits it to a computer device to train ML models that estimate an absolute value of ICP
The basic science behind this method for measuring ICP is that changes in the extramural arterial pressure affect the morphology of the recorded optical pulse so analysis of the acquired signal using an appropriate algorithm will enable calculation of nICP The reported nICP will provide screening at the triage stage indicating the need for imaging or rapid intervention such as haematoma evacuation and guide head injury management notably ICP-targeted treatment regimes Ultimately this could lead to significant improvements in secondary injury-related mortality length of hospital stay and reduced post-trauma disability
This feasibility study aims to collect the clinical data with which to train the nICP algorithms to the point that they can detect raised intracranial pressure ICP20 mmHg with sufficient sensitivity and specificity that Crainio device can be regulated for clinical use
Standard ICP monitoring requires insertion of a cranial bolt into the skull through which an electrical transducer is inserted Alternatively an intra-ventricular catheter is inserted through a burr hole Both of these monitoring methods are associated with risks including haemorrhage and infection as well as delay in establishing emergency monitoring and limiting it to hospitals that have neurosurgery
There has been much research in recent years to find a method for measuring intracranial pressure noninvasively nICP including measurement of pressure in the retinal veins measurement of eardrum displacement transcranial Doppler ultrasonography and imaging-based solutions These methods all require considerable user intervention and are non-continuous
This project aims to collect cerebral photoplethysmogram signals and concurrent invasive ICP measurements from patients with traumatic brain injury to develop Crainio machine learning ML algorithms The core intellectual property IP of this continuous external monitoring ICP system was originally developed by academics in the lab of Professor Kyriacou at City University of London Crainio is a spin-out company that was created to industrialise and commercialise this research on an exclusive basis
The device comprises a forehead-mounted sensor containing infrared light sources that can illuminate the deep brain tissue of the frontal lobe Photodetectors in the sensor detect the backscattered light which is modulated by pulsation of the cerebral arteries A control unit processes the backscattered light called the photoplethysmogram PPG and transmits it to a computer device to train ML models that estimate an absolute value of ICP
The basic science behind this method for measuring ICP is that changes in the extramural arterial pressure affect the morphology of the recorded optical pulse so analysis of the acquired signal using an appropriate algorithm will enable calculation of nICP The reported nICP will provide screening at the triage stage indicating the need for imaging or rapid intervention such as haematoma evacuation and guide head injury management notably ICP-targeted treatment regimes Ultimately this could lead to significant improvements in secondary injury-related mortality length of hospital stay and reduced post-trauma disability
This feasibility study aims to collect the clinical data with which to train the nICP algorithms to the point that they can detect raised intracranial pressure ICP20 mmHg with sufficient sensitivity and specificity that Crainio device can be regulated for clinical use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None