Traumatic Brain InjuryNCT05632302
A Non-invasive Intracranial Pressure (nICP) Monitoring System
A study testing nICP in people with Traumatic Brain Injury and Intracranial Hypertension, run by Crainio Ltda at 1 site in United Kingdom.
Trial summary
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hypertension
- What is being tested?
- nICP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2020to 20 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient admitted to the Royal London Hospital who is having invasive ICP monitoring as part of their normal medical care
- Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent. If the patient is unconscious, and a consultee is not available then a professional consultee (a doctor looking after the patient who is not involved in the trial) will assent to inclusion in the trial and non-invasive ICP monitoring will be performed.
Who cannot join
- Patients with decompressive craniectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Estimate Intracranial Pressure Noninvasively in Traumatic Brain Injury Patients
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. Changes in the extramural arterial pressure affect the morphology of the recorded optical pulse, so analysis of the acquired signal using an appropriate algorithm could enable the calculation of the intracranial pressure noninvasively (nICP), which would be displayed to clinicians continuously.
This pilot study is the first evaluation of the device in patients in who the gold standard comparator of invasive ICP was available. The acquisition of pulsatile optical signals was performed for up to 48 hours in each of the 40 patients who were undergoing invasive ICP monitoring as part of their normal medical treatment.
Features of the optical signals would be analysed offline. A machine vector support algorithm would be implemented, with the aim of estimating ICP noninvasively and compared to the gold standard of synchronously acquired invasive ICP data.
Read the detailed description
Traumatic brain injury (TBI) is the most common cause of death and disability in the under 40 age group both in the United Kingdom and worldwide, and prevalence is increasing. The mainstay of severe TBI management is intracranial pressure (ICP) measurement. ICP is defined as the pressure within the skull and brain. TBI often causes a rise in ICP as the brain swells within the rigid skull and therapy is directed at keeping this pressure at an acceptable level with medications or surgery. Very high ICP may lead to further brain damage resulting in increased disability or death.
Existing techniques to measure ICP involve placing an electrical sensor into the brain tissue through a small hole drilled in the skull. This procedure risks infection and bleeding into the brain and can only be performed by a neurosurgeon. Therefore, there is a vital demand to develop non-invasive technologies that will allow measuring the ICP without inserting a sensor in the brain. This technology will decrease the risks, permit monitoring outside the hospital (eg in an ambulance) and reduce the costs. It will also increase the indication for ICP monitoring to include other conditions (e.g. stroke or brain tumours) which are not currently monitored.
The proposed non-invasive ICP (nICP) monitor works by shining a harmless light into the brain through the skull. The developed sensor was attached to the skin of the forehead and recorded optical signals (known as photoplethysmography (PPG)) from the brain, which are related to changes in the ICP. This pilot aims to build the first clinical database of nICP signals in intensive care patients. The acquisition of an extensive set of signals would allow the generation of advanced algorithms and Machine Learning (ML) models utilising optical signal feature extraction techniques. The resulting model will be implemented in translating the optical signals into absolute measurements of ICP.
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Being tested
- nICP
- Keywords
- Intracranial pressure, Near infrared spectroscopy, Photoplethysmography, Noninvasive monitoring
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nICPDevice
The nICP probe contains infrared light sources that illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries.
| Study group | Role | What they receive |
|---|---|---|
| TBI-ICP monitoring | Experimental | Optical signals acquisition from the nICP probe stuck to the patient's forehead Receives: Device: nICP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Machine learning model agreement
Bland-Altman limits of agreement between the offline estimation of nICP and the invasive ICP measurements
Measured: 48 hours record per patient
Secondary outcomes (1)
Machine learning model diagnostic accuracy
Sensitivity and specificity of the offline nICP estimation to identify ICP values over 20 mmHg
Measured: 48 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 posted30 Nov 2022
- Study start20 Jan 2020
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crainio Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- City, University of London, Barts & The London NHS Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Christopher Uff, FRCS, Principal investigator, Consultant Neurosurgeon (Royal London Hosptial)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632302
- Sponsor's protocol ID
- 219476
- Status last verified
- Nov 2022
- First submitted
- 11 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the final results of the nICP safety and accuracy would be published. Any individual participant data would be available to other researchers.
Publications
Head injury: assessment and early management. London: National Institute for Health and Care Excellence (NICE); 2019 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK552670/
PubMed 31944644Lawrence T, Helmy A, Bouamra O, Woodford M, Lecky F, Hutchinson PJ. Traumatic brain injury in England and Wales: prospective audit of epidemiology, complications and standardised mortality. BMJ Open. 2016 Nov 24;6(11):e012197. doi: 10.1136/bmjopen-2016-012197.
PubMed 27884843Raboel PH, Bartek J Jr, Andresen M, Bellander BM, Romner B. Intracranial Pressure Monitoring: Invasive versus Non-Invasive Methods-A Review. Crit Care Res Pract. 2012;2012:950393. doi: 10.1155/2012/950393. Epub 2012 Jun 8.
PubMed 22720148Kawoos U, McCarron RM, Auker CR, Chavko M. Advances in Intracranial Pressure Monitoring and Its Significance in Managing Traumatic Brain Injury. Int J Mol Sci. 2015 Dec 4;16(12):28979-97. doi: 10.3390/ijms161226146.
PubMed 26690122Nag DS, Sahu S, Swain A, Kant S. Intracranial pressure monitoring: Gold standard and recent innovations. World J Clin Cases. 2019 Jul 6;7(13):1535-1553. doi: 10.12998/wjcc.v7.i13.1535.
PubMed 31367614Roldan 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. 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, 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 38409283
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Estimate Intracranial Pressure Noninvasively in Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT05632302
- Acronym / sponsor ID
- 219476
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Keywords
- Intracranial pressure, Near infrared spectroscopy, Photoplethysmography, Noninvasive monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Crainio LtdaIndustry (pharma, biotech, devices)
- Collaborators
- City, University of London, Barts & The London NHS Trust, National Institute for Health Research, United Kingdom
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 30 Nov 2022 (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.
Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. Changes in the extramural arterial pressure affect the morphology of the recorded optical pulse, so analysis of the acquired signal using an appropriate algorithm could enable the calculation of the intracranial pressure noninvasively (nICP), which would be displayed to clinicians continuously.
This pilot study is the first evaluation of the device in patients in who the gold standard comparator of invasive ICP was available. The acquisition of pulsatile optical signals was performed for up to 48 hours in each of the 40 patients who were undergoing invasive ICP monitoring as part of their normal medical treatment.
Features of the optical signals would be analysed offline. A machine vector support algorithm would be implemented, with the aim of estimating ICP noninvasively and compared to the gold standard of synchronously acquired invasive ICP data.
Detailed description
Traumatic brain injury (TBI) is the most common cause of death and disability in the under 40 age group both in the United Kingdom and worldwide, and prevalence is increasing. The mainstay of severe TBI management is intracranial pressure (ICP) measurement. ICP is defined as the pressure within the skull and brain. TBI often causes a rise in ICP as the brain swells within the rigid skull and therapy is directed at keeping this pressure at an acceptable level with medications or surgery. Very high ICP may lead to further brain damage resulting in increased disability or death.
Existing techniques to measure ICP involve placing an electrical sensor into the brain tissue through a small hole drilled in the skull. This procedure risks infection and bleeding into the brain and can only be performed by a neurosurgeon. Therefore, there is a vital demand to develop non-invasive technologies that will allow measuring the ICP without inserting a sensor in the brain. This technology will decrease the risks, permit monitoring outside the hospital (eg in an ambulance) and reduce the costs. It will also increase the indication for ICP monitoring to include other conditions (e.g. stroke or brain tumours) which are not currently monitored.
The proposed non-invasive ICP (nICP) monitor works by shining a harmless light into the brain through the skull. The developed sensor was attached to the skin of the forehead and recorded optical signals (known as photoplethysmography (PPG)) from the brain, which are related to changes in the ICP. This pilot aims to build the first clinical database of nICP signals in intensive care patients. The acquisition of an extensive set of signals would allow the generation of advanced algorithms and Machine Learning (ML) models utilising optical signal feature extraction techniques. The resulting model will be implemented in translating the optical signals into absolute measurements of ICP.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBI-ICP monitoring | Experimental | Device: nICPOptical signals acquisition from the nICP probe stuck to the patient's forehead |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient admitted to the Royal London Hospital who is having invasive ICP monitoring as part of their normal medical care
- Subject is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent. If the patient is unconscious, and a consultee is not available then a professional consultee (a doctor looking after the patient who is not involved in the trial) will assent to inclusion in the trial and non-invasive ICP monitoring will be performed.
Key exclusion criteria (1 listed)
- Patients with decompressive craniectomy
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 |
|---|---|---|
| nICPThe nICP probe contains infrared light sources that illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. | Device | TBI-ICP monitoring |
Primary outcome
Machine learning model agreement
Time frame: 48 hours record per patient
Bland-Altman limits of agreement between the offline estimation of nICP and the invasive ICP measurements
1 secondary outcome
Machine learning model diagnostic accuracy
Time frame: 48 hours record per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Background: PubMed 31944644Head injury: assessment and early management. London: National Institute for Health and Care Excellence (NICE); 2019 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK552670/
- Background: PubMed 27884843Lawrence T, Helmy A, Bouamra O, Woodford M, Lecky F, Hutchinson PJ. Traumatic brain injury in England and Wales: prospective audit of epidemiology, complications and standardised mortality. BMJ Open. 2016 Nov 24;6(11):e012197. doi: 10.1136/bmjopen-2016-012197.
- Background: PubMed 22720148Raboel PH, Bartek J Jr, Andresen M, Bellander BM, Romner B. Intracranial Pressure Monitoring: Invasive versus Non-Invasive Methods-A Review. Crit Care Res Pract. 2012;2012:950393. doi: 10.1155/2012/950393. Epub 2012 Jun 8.
- Background: PubMed 26690122Kawoos U, McCarron RM, Auker CR, Chavko M. Advances in Intracranial Pressure Monitoring and Its Significance in Managing Traumatic Brain Injury. Int J Mol Sci. 2015 Dec 4;16(12):28979-97. doi: 10.3390/ijms161226146.
- Background: PubMed 31367614Nag DS, Sahu S, Swain A, Kant S. Intracranial pressure monitoring: Gold standard and recent innovations. World J Clin Cases. 2019 Jul 6;7(13):1535-1553. doi: 10.12998/wjcc.v7.i13.1535.
- 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 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.
- Derived from this study: 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.
- Individual participant dataSharing planned: No. Only the final results of the nICP safety and accuracy 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. This study is not recruiting at the moment.
Christopher Uff, FRCS principal investigator
Consultant Neurosurgeon (Royal London Hosptial)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nICP in people with Traumatic Brain Injury and Intracranial Hypertension, 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Machine learning model agreement (time frame: 48 hours record per patient). 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 NCT05632302, 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 30 Nov 2022.