Evaluating Near-infrared Spectroscopy Devices for Monitoring Traumatic Brain Injury

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.

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.