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Evaluating Near-infrared Spectroscopy Devices for Monitoring Traumatic Brain Injury

NCT07106216 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2025-08-06

No results posted yet for this study

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. 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.

Conditions

  • Tramatic Brain Injury

Sponsors & Collaborators

  • Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK

    collaborator UNKNOWN

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • University of Cambridge

    lead OTHER

Principal Investigators

  • Peter Smielewski, PhD · Cambridge University Hospitals

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-12-31
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07106216 on ClinicalTrials.gov