Crainio non-invasive intracranial pressure monitor for TBI
Research type
Research Study
Full title
Crainio non-invasive intracranial pressure monitor for traumatic brain injury: product development
IRAS ID
341050
Contact name
Jeremy Holland
Contact email
Sponsor organisation
Crainio Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Crainio is a London-based SME developing a revolutionary medical device for non-invasively measuring intracranial pressure.
The current clinical method for measuring ICP involves a neurosurgeon inserting an electrical sensor directly into the brain tissue through a small hole drilled in the skull and leaving it there for ~72 hours. This is risky, expensive and logistically very challenging for healthcare providers.
Crainio completely overcomes these problems, creating a way to radically transform the care and outcomes of people with traumatic brain injury, which is the commonest cause of death and disability in people <40 in the UK and worldwide. The revolutionary technology comprises a small probe that is temporarily stuck to the patient’s forehead using adhesive and shines harmless near-infrared light through the skull and into the brain. The probe measures intracranial pressure by extracting, processing and analysing key information from the photoplethysmography signal that returns to the forehead using cutting-edge artificial intelligence.
Proof-of-concept of this patent pending technology has been established in a study on healthy volunteers, a study on a brain phantom, and a clinical study on 40 patients with severe traumatic brain injury in the ICU.
This project, funded by Innovate UK, aims to increase the accuracy of Crainio's machine-learning algorithms to the point that they can detect raised intracranial pressure with sufficient sensitivity and specificity to regulate the device for clinical use. This will be done by collecting photoplethysmogram data and concurrent invasive probe data from 54 patients with traumatic brain injury in Barts Health NHS Trust ICU. This clinical study, which will be led by distinguished neurosurgeon Dr Chris Uff, will feature Crainio’s new, improved probe for the purpose of collecting the high-quality photoplethysmography signals.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/LO/0554
Date of REC Opinion
1 Oct 2024
REC opinion
Further Information Favourable Opinion