Traumatic Brain InjuryNCT06453733
Crainio Non-invasive ICP Monitor for TBI
A study testing Crainio in people with Traumatic Brain Injury, run by Crainio Ltda at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Crainio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2025to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Forehead skin is not intact.
- Decompressive craniectomy patients.
- Open external ventricular drainage (EVD) treatment.
- Patients who will unlikely survive the following twelve hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal London Hospital
London, England, E1 1BB
Christopher Uff, Prof, 020 3594 2797, Chris.uff@bartshealth.nhs.uk
Maria Roldan, Dr, 07737000015, maria.roldan@crainio.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Crainio
- Keywords
- Intracranial pressure, Non-invasive monitoring, Machine learning, Photoplethysmography
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrainioDevice
Also called nICP probe, Crainio system
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.
| Study group | Role | What they receive |
|---|---|---|
| Crainio | Experimental | 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 Receives: Device: Crainio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Generate a nICP model offline with a sensitivity above 90% to discriminate ICP values over 20 mmHg.
Measured: 12 hours record per patient
Specificity
Generate a nICP model offline with a specificity above 90% to discriminateICP values over 20 mmHg.
Measured: 12 hours record per patient
Secondary outcomes (5)
Skin tone through Fitzpatrick scale
Evaluating the effect on the nICP model of patient-related factors such as the skin tone.
Measured: 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.
Measured: 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.
Measured: 1 classification per patient (1 minute)
Device usability
Customised form to assess the acceptance of the device by the healthcare proffesionals.
Measured: 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
Measured: 12 hours record per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start15 May 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Crainio Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovate UK, Barts & The London NHS Trust, City, University of London
- Responsible party
- Sponsor
- Investigators
- Chris Uff, Dr, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453733
- Sponsor's protocol ID
- 341050
- Status last verified
- Mar 2026
- First submitted
- 30 May 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the final results of Crainio device diagnostic accuracy and safety would be published. Any individual participant data would be available to other researchers.
Publications
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.
PubMed 33668311Roldan 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.
PubMed 32821023Roldan 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.
PubMed 34891522Roldan 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.
PubMed 36085774Roldan 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.
PubMed 37614754Roldan 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.
PubMed 38409283M. 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 at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crainio Non-invasive Intracranial Pressure Monitor for Traumatic Brain Injury: Product Development
- ClinicalTrials.gov ID
- NCT06453733
- Acronym / sponsor ID
- 341050
- Conditions
- Traumatic Brain Injury
- Keywords
- Intracranial pressure, Non-invasive monitoring, Machine learning, Photoplethysmography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Crainio LtdaIndustry (pharma, biotech, devices)
- Collaborators
- Innovate UK, Barts & The London NHS Trust, City, University of London
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (ICP>20 mmHg) with sufficient sensitivity and specificity that Crainio device can be regulated for clinical use.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crainio | Experimental | Device: CrainioAcquisition 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 |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Forehead skin is not intact.
- Decompressive craniectomy patients.
- Open external ventricular drainage (EVD) treatment.
- Patients who will unlikely survive the following twelve hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrainioAlso: nICP probe, Crainio systemCrainio 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. | Device | Crainio |
Primary outcome
Sensitivity
Time frame: 12 hours record per patient
Generate a nICP model offline with a sensitivity above 90% to discriminate ICP values over 20 mmHg.
Specificity
Time frame: 12 hours record per patient
Generate a nICP model offline with a specificity above 90% to discriminateICP values over 20 mmHg.
5 secondary outcomes
Skin tone through Fitzpatrick scale
Time frame: 1 classification per patient (3 minutes)
Skull thickness through CT scan
Time frame: 1 measurement per patient (3 minutes)
Skull density through Age stratification analysis
Time frame: 1 classification per patient (1 minute)
Device usability
Time frame: 1 form per patient (5 minutes)
Advers effects and events
Time frame: 12 hours record per patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 33668311Roldan M, Kyriacou PA. Near-Infrared Spectroscopy (NIRS) in Traumatic Brain Injury (TBI). Sensors (Basel). 2021 Feb 24;21(5):1586. doi: 10.3390/s21051586.
- Background: PubMed 32821023Roldan 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.
- Background: PubMed 34891522Roldan 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.
- Background: PubMed 36085774Roldan 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.
- Background: PubMed 37614754Roldan 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.
- Background: PubMed 38409283Roldan 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.
- BackgroundM. 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
- BackgroundT. 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
- BackgroundM. 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
- Individual participant dataSharing planned: No. Only the final results of Crainio device diagnostic accuracy and safety would be published. Any individual participant data would be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Uff, Dr principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crainio in people with Traumatic Brain Injury, run by Crainio Ltda at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Holland, Dr (0779 626 5994, Jeremy.Holland@crainio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 12 hours record per patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06453733, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.