Evaluating Near-infrared Spectroscopy Devices for Monitoring Traumatic Brain Injury

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

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."

Exclusion Criteria:

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07106216
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Cambridge
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Peter Smielewski, PhD
Principal Investigator Affiliation	Cambridge University Hospitals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Tramatic Brain Injury

Additional Details

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.

Arms & Interventions

Arms

: Severe brain injury

Those with severe (as defined by the Glasgow Coma Scale) brain injuries

Interventions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Cameron Smith, MSc, MRes

[email protected]

01223 748300

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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