Crainio Non-invasive ICP Monitor for TBI

Crainio Non-invasive Intracranial Pressure Monitor for Traumatic Brain Injury: Product Development

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: Crainio

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 (ICP>20 mmHg) with sufficient sensitivity and specificity that Crainio device can be regulated for clinical use.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy Holland, Dr; Phone Number: 0779 626 5994; Email: Jeremy.Holland@crainio.com

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, E1 1BB
      • Recruiting
      • Royal London Hospital
      • Contact: Christopher Uff, Prof; Phone Number: 020 3594 2797; Email: Chris.uff@bartshealth.nhs.uk
      • Contact: Maria Roldan, Dr; Phone Number: 07737000015; Email: maria.roldan@crainio.com
      • Principal Investigator: Christopher Uff, Dr
      • Sub-Investigator: Maria Roldan, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of traumatic brain injury.
• Adults (aged between 16 and 99, male and female)
• TBI patients admitted to the Royal London Hospital.
• Patients having invasive ICP monitoring as part of their normal medical treatment.

Exclusion Criteria:

• Forehead skin is not intact.
• Decompressive craniectomy patients.
• Open external ventricular drainage (EVD) treatment.
• Patients who will unlikely survive the following twelve hours.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Crainio; Acquisition of cerebral PPG signals from Crainio's probe stuck to the patient's forehead, alongside concurrent invasive ICP measurements in patients with traumatic brain injury

Device: Crainio; Crainio 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 will estimate ICP offline.; Other Names: nICP probe, Crainio system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Generate a nICP model offline with a sensitivity above 90% to discriminate ICP values over 20 mmHg.	12 hours record per patient
Specificity	Generate a nICP model offline with a specificity above 90% to discriminateICP values over 20 mmHg.	12 hours record per patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin tone through Fitzpatrick scale	Evaluating the effect on the nICP model of patient-related factors such as the skin tone.	1 classification per patient (3 minutes)
Skull thickness through CT scan	Evaluating the effect on the nICP model of patient-related factors such as the skull thickness.	1 measurement per patient (3 minutes)
Skull density through Age stratification analysis	Evaluating the effect on the nICP model of patient-related factors such as the skull density.	1 classification per patient (1 minute)
Device usability	Customised form to assess the acceptance of the device by the healthcare proffesionals.	1 form per patient (5 minutes)
Advers effects and events	Evaluate the device safety by monitoring the development of possible advers effects or events in the patients while data is acquired	12 hours record per patient

Collaborators and Investigators

• Sponsor: Crainio Ltda
• Collaborators: Barts & The London NHS Trust; City, University of London; Innovate UK
• Investigators: Principal Investigator: Chris Uff, Dr, Barts & The London NHS Trust

Publications and helpful links

General Publications

• Roldan M, Chatterjee S, Kyriacou PA. Brain Light-Tissue Interaction Modelling: Towards a non-invasive sensor for Traumatic Brain Injury. Annu Int Conf IEEE Eng Med Biol Soc. 2021 Nov;2021:1292-1296. doi: 10.1109/EMBC46164.2021.9630909.
• Roldan M, Kyriacou PA. Near-Infrared Spectroscopy (NIRS) in Traumatic Brain Injury (TBI). Sensors (Basel). 2021 Feb 24;21(5):1586. doi: 10.3390/s21051586.
• Roldan M, Abay TY, Kyriacou PA. Non-Invasive Techniques for Multimodal Monitoring in Traumatic Brain Injury: Systematic Review and Meta-Analysis. J Neurotrauma. 2020 Dec 1;37(23):2445-2453. doi: 10.1089/neu.2020.7266. Epub 2020 Sep 24.
• Roldan M, Kyriacou PA. Head Phantom Optical Properties Validation for Near-Infrared Measurements: A Comparison with Animal Tissue. Annu Int Conf IEEE Eng Med Biol Soc. 2022 Jul;2022:641-644. doi: 10.1109/EMBC48229.2022.9871103.
• Roldan M, Bradley GRE, Mejia-Mejia E, Abay TY, Kyriacou PA. Non-invasive monitoring of intracranial pressure changes: healthy volunteers study. Front Physiol. 2023 Aug 8;14:1208010. doi: 10.3389/fphys.2023.1208010. eCollection 2023.
• Roldan M, Abay TY, Uff C, Kyriacou PA. A pilot clinical study to estimate intracranial pressure utilising cerebral photoplethysmograms in traumatic brain injury patients. Acta Neurochir (Wien). 2024 Feb 27;166(1):109. doi: 10.1007/s00701-024-06002-4.
• M. Roldan and P. A. Kyriacou, Head Phantom for the Acquisition of Pulsatile Optical Signals for Traumatic Brain Injury Monitoring, Photonics, vol. 10, no. 5, 2023
• T. Y. Abay, J. P. Phillips, C. Uff, M. Roldan, and P. A. Kyriacou, In Vitro Evaluation of a Non-Invasive Photoplethysmography Based Intracranial Pressure Sensor, Appl. Sci., vol. 13, no. 1, p. 534, Dec. 2022
• M. Roldan and P. A. Kyriacou, "A non-Invasive Optical Multimodal Photoplethysmography-Near Infrared Spectroscopy Sensor for Measuring Intracranial Pressure and Cerebral Oxygenation in Traumatic Brain Injury," Appl. Sci., 2023

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Photoplethysmography; Intracranial pressure; Machine learning; Non-invasive monitoring
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 341050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only the final results of Crainio device diagnostic accuracy and safety would be published. Any individual participant data would be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No