Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
54 participants
INTERVENTIONAL
2024-09-15
2025-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
NCT04900168
Transcranial Doppler on Admission of Patients With Mild to Moderate Traumatic Brain Injury
NCT01291706
Comparison of the Application in Traumatic Brain Edema Between EIT and Non-invasive ICP Monitoring
NCT02027857
Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy.
NCT02745210
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
NCT02773888
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Decompressive craniectomy patients.
* Open external ventricular drainage (EVD) treatment.
* Patients who will unlikely survive the following twelve hours.
16 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovate UK
OTHER_GOV
Barts & The London NHS Trust
OTHER
City, University of London
OTHER
Crainio Ltda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chris Uff, Dr
Role: PRINCIPAL_INVESTIGATOR
Barts & The London NHS Trust
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal London Hospital
London, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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, 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. 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
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
341050
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.