Crainio non-invasive intracranial pressure monitor for traumatic brain injury: product development

Crainio is a London-based SME developing a revolutionary medical device for non-invasively measuring intracranial pressure (ICP).

The current clinical method for monitoring 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 a brain phantom and a basic science study on 40 patients with severe traumatic brain injury in the ICU. This study received the Gold Award Prize at the STEM for Britain 2020 event held at the House of Commons and led to Crainio's Chief Technology Officer winning the Engineers Mercia Award 2022\.

This BMC project aims to develop the Crainio machine learning algorithms to the point that they can detect raised intracranial pressure with sufficient sensitivity and specificity that the device can be regulated 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.

Crainio is a spin-out from City, University of London. The research was developed by Professor Kyriacou's lab, which is world-renowned for research in understanding and developing applications of non-invasive optical sensors to facilitate prognosis, diagnosis and treatment of disease.

The project is supported by the National Institute of Health and Care Research Brain Injury Medtech and In vitro Diagnostics Co-operative, including Professor Marek Czosnyka and Dr Peter Smielewski (the MIC's intracranial pressure monitoring theme leads), who are both based at University of Cambridge.