Tramatic Brain InjuryNIRS in TBINCT07106216
Evaluating Near-infrared Spectroscopy Devices for Monitoring Traumatic Brain Injury
An observational study of Tramatic Brain Injury, run by University of Cambridge.
Trial summary
This project seeks to evaluate the capabilities of new Near Infrared Spectroscopy (NIRS) devices, which use light to measure brain activity, for monitoring how the brain and body react after a serious head injury (TBI), particularly in the immediate and shortly following periods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tramatic Brain Injury
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Sep 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Addenbookes (Cambridge, UK) neuro critical care ward patients
Who may be able to join
- Those in the Neuro Critical Care Unit at Addenbrooke's (Cambridge, UK) AND
- Patients with moderate or severe head trauma AND
- Over 18 AND
- Those with intracranial pressure monitoring probes."
Who cannot join
- We will not monitor anyone aged under 18 OR
- We will not monitor anyone with penetrating wounds in the area we want to monitor OR
- Patients who are enrolled on >2 other research studies, as per local guidelines OR
- Moribund at presentation OR
- Those with infectious diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gemma Bale, PhD contact
About this study
Official title: Evaluating Two Novel Near-infrared Spectroscopy Devices for Non-invasive Monitoring of Traumatic Brain Injury in the Neuro Critical Care Unit.
This project seeks to evaluate the capabilities of new Near Infrared Spectroscopy (NIRS) devices, which use light to measure brain activity, for monitoring how the brain and body react after a serious head injury (TBI), particularly in the immediate and shortly following periods. Data recorded from these devices will help determine if they can effectively monitor additional complications and outcomes in adults over 18 with severe TBIs in a specialised intensive care unit for brain injuries (NCCU) at Addenbrooke's Hospital (Cambridge, UK). We will use two different NIRS devices similar to those currently used in the NCCU but with extra improvements. Both devices are proven to be safe and do not require surgery or internal procedures.
Participants will be recruited based on several criteria and monitored early in their NCCU admission. Monitoring will be daily for 6 hours, lasting from half a week to two weeks, depending on recovery progress. After the initial 10 patients, we will perform an interim analysis and may adjust the recording duration. We aim to recruit a maximum of 50 participants in total. Due to their condition, participants will not be able to give permission to participate, so we will seek it from their next of kin within 24 hours of admission. The study will only observe and not influence treatment. We will also collect additional clinical data, such as scans, the patient's condition six months after the injury, and other medical information for analysis.
The data collection period for this study will last up to 2 years. We will remove any personal details from the patient data. The body function data, with personal details removed, will be transferred and stored on the Brain Physics Lab server (segregated) and University of Cambridge computers for analysis. Any data not saved in dedicated long-term storage will be deleted after use.
Read the detailed description
This study will apply novel near-infrared spectroscopy (NIRS) devices within the neurocritical care unit (NCCU) in Addenbrooke's Hospital (Cambridge, UK). The devices are non-invasive and are shown to be safe. The study is expected to last around year. It will not be used to inform treatment, and patient care is to remain identical regardless of study inclusion.
This study will use two NIRS devices, both of which have enhancements over systems used within the NCCU currently. We aim to develop NIRS-based biomarkers that could be used to support the treatment of those suffering from traumatic brain injury (TBI).
Upon receiving advice from the patient's consultee, the participant will be recorded with two different NIRS devices for a total of six hours daily (three hours per device). Recordings will occur daily for the duration of the participant's admission to the NCCU. We request access to clinical data, for example, blood pressure, heart rate, injuries suffered, CT and MRI scans and six-month outcomes for analytical purposes. As the devices are light-based, skin tone or ethnicity data is requested as is age-band for subject-specific modelling. This data will then be used to develop metrics based on existing literature that describe the brain health of the participant.
Participants will be unable to provide informed consent. Therefore, we will seek advice from their next of kin or in the event they cannot be identified within 24 hours, the treating clinician.
Participants will be those in the NCCU. They will be suffering from moderate or severe TBI. It is very likely they will be in an unconscious state. The study is limited to adults (defined as ≥18 years of age).
Two devices are planned for use in this study. The first device is a Lumo (Gowerlabs Ltd, UK), a high-density diffuse optical tomography device. This device is a modified version of a CE-marked device. The second is a custom broadband NIRS device that has met all legal and regulatory requirements. It is assembled out of CE-marked components although the device itself is not CE-marked.
We aim to start patient recordings to start in Q2 2025. The maximum number of participants for this study is set to 50. The end date is set at the 31st of December 2025.
By recording with these devices, we hope to develop new methods for monitoring TBI- an injury that impacts tens of millions annually. The novelty of this study comes from the devices applied. They have only been applied in a limited context previously within TBI cohorts, although are common in research. This study will be used to inform future studies which we hope will ultimately lead to improved patient care.
- Conditions
- Tramatic Brain Injury
- Keywords
- brain, head, injury, severe, nirs
- Medical subject headings
- Wounds and Injuries, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Severe brain injury | Those with severe (as defined by the Glasgow Coma Scale) brain injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Score Extended
The Glasgow Outcome Scale-Extended (GOSE) is a detailed assessment tool used to evaluate the functional status and recovery of patients following traumatic brain injury (TBI), categorizing outcomes into eight levels ranging from death to full recovery. It helps clinicians and researchers understand the long-term impact of TBI on a patient's daily life and guides treatment and rehabilitation efforts. Lower numbers are worse (1=dead). Higher numbers are better (8=Good recovery).
Measured: 6 months after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tramatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK, Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Peter J. Hutchinson MD, University of Cambridge
- Investigators
- Peter Smielewski, PhD, Study director, Cambridge University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106216
- Sponsor's protocol ID
- IRAS 330193
- Other IDs
- EP/S022139/1
- Acronym
- NIRS in TBI
- Status last verified
- Jul 2025
- First submitted
- 14 May 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have permission to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Two Novel Near-infrared Spectroscopy Devices for Non-invasive Monitoring of Traumatic Brain Injury in the Neuro Critical Care Unit.
- ClinicalTrials.gov ID
- NCT07106216
- Acronym / sponsor ID
- NIRS in TBI / IRAS 330193
- Conditions
- Tramatic Brain Injury
- Keywords
- brain, head, injury, severe, nirs
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK, Cambridge University Hospitals NHS Foundation Trust
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 6 Aug 2025 (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.
This project seeks to evaluate the capabilities of new Near Infrared Spectroscopy (NIRS) devices, which use light to measure brain activity, for monitoring how the brain and body react after a serious head injury (TBI), particularly in the immediate and shortly following periods. Data recorded from these devices will help determine if they can effectively monitor additional complications and outcomes in adults over 18 with severe TBIs in a specialised intensive care unit for brain injuries (NCCU) at Addenbrooke's Hospital (Cambridge, UK). We will use two different NIRS devices similar to those currently used in the NCCU but with extra improvements. Both devices are proven to be safe and do not require surgery or internal procedures.
Participants will be recruited based on several criteria and monitored early in their NCCU admission. Monitoring will be daily for 6 hours, lasting from half a week to two weeks, depending on recovery progress. After the initial 10 patients, we will perform an interim analysis and may adjust the recording duration. We aim to recruit a maximum of 50 participants in total. Due to their condition, participants will not be able to give permission to participate, so we will seek it from their next of kin within 24 hours of admission. The study will only observe and not influence treatment. We will also collect additional clinical data, such as scans, the patient's condition six months after the injury, and other medical information for analysis.
The data collection period for this study will last up to 2 years. We will remove any personal details from the patient data. The body function data, with personal details removed, will be transferred and stored on the Brain Physics Lab server (segregated) and University of Cambridge computers for analysis. Any data not saved in dedicated long-term storage will be deleted after use.
Detailed description
This study will apply novel near-infrared spectroscopy (NIRS) devices within the neurocritical care unit (NCCU) in Addenbrooke's Hospital (Cambridge, UK). The devices are non-invasive and are shown to be safe. The study is expected to last around year. It will not be used to inform treatment, and patient care is to remain identical regardless of study inclusion.
This study will use two NIRS devices, both of which have enhancements over systems used within the NCCU currently. We aim to develop NIRS-based biomarkers that could be used to support the treatment of those suffering from traumatic brain injury (TBI).
Upon receiving advice from the patient's consultee, the participant will be recorded with two different NIRS devices for a total of six hours daily (three hours per device). Recordings will occur daily for the duration of the participant's admission to the NCCU. We request access to clinical data, for example, blood pressure, heart rate, injuries suffered, CT and MRI scans and six-month outcomes for analytical purposes. As the devices are light-based, skin tone or ethnicity data is requested as is age-band for subject-specific modelling. This data will then be used to develop metrics based on existing literature that describe the brain health of the participant.
Participants will be unable to provide informed consent. Therefore, we will seek advice from their next of kin or in the event they cannot be identified within 24 hours, the treating clinician.
Participants will be those in the NCCU. They will be suffering from moderate or severe TBI. It is very likely they will be in an unconscious state. The study is limited to adults (defined as ≥18 years of age).
Two devices are planned for use in this study. The first device is a Lumo (Gowerlabs Ltd, UK), a high-density diffuse optical tomography device. This device is a modified version of a CE-marked device. The second is a custom broadband NIRS device that has met all legal and regulatory requirements. It is assembled out of CE-marked components although the device itself is not CE-marked.
We aim to start patient recordings to start in Q2 2025. The maximum number of participants for this study is set to 50. The end date is set at the 31st of December 2025.
By recording with these devices, we hope to develop new methods for monitoring TBI- an injury that impacts tens of millions annually. The novelty of this study comes from the devices applied. They have only been applied in a limited context previously within TBI cohorts, although are common in research. This study will be used to inform future studies which we hope will ultimately lead to improved patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe brain injury | – | –Those with severe (as defined by the Glasgow Coma Scale) brain injuries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Addenbookes (Cambridge, UK) neuro critical care ward patients
Key inclusion criteria (4 listed)
- Those in the Neuro Critical Care Unit at Addenbrooke's (Cambridge, UK) AND
- Patients with moderate or severe head trauma AND
- Over 18 AND
- Those with intracranial pressure monitoring probes."
Key exclusion criteria (5 listed)
- We will not monitor anyone aged under 18 OR
- We will not monitor anyone with penetrating wounds in the area we want to monitor OR
- Patients who are enrolled on >2 other research studies, as per local guidelines OR
- Moribund at presentation OR
- Those with infectious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glasgow Outcome Score Extended
Time frame: 6 months after admission
The Glasgow Outcome Scale-Extended (GOSE) is a detailed assessment tool used to evaluate the functional status and recovery of patients following traumatic brain injury (TBI), categorizing outcomes into eight levels ranging from death to full recovery. It helps clinicians and researchers understand the long-term impact of TBI on a patient's daily life and guides treatment and rehabilitation efforts. Lower numbers are worse (1=dead). Higher numbers are better (8=Good recovery).
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 6 Aug 2025.
- Individual participant dataSharing planned: No. We do not have permission to share IPD
Related trials for Tramatic Brain Injury
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.
Gemma Bale, PhD contact
Peter Smielewski, PhD study director
Cambridge University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Tramatic Brain Injury, run by University of Cambridge.
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 5 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: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Cameron Smith, MSc, MRes (01223 748300, cs2159@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Score Extended (time frame: 6 months after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2025.