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NIRS in TBI
Evaluating Two Novel Near-infrared Spectroscopy Devices for Non-invasive Monitoring of Traumatic Brain Injury in the Neuro Critical Care Unit.
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · EPSRC
observational
10
0 countries
N/A
Study Start
August 1, 2025
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Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2025
Actual (reported)August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 6, 2025
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
6 months after admission
Those with severe (as defined by the Glasgow Coma Scale) brain injuries
Addenbookes (Cambridge, UK) neuro critical care ward patients
Peter Smielewski, PhD
Cambridge University Hospitals
First Submitted
May 14, 2025
First Posted
August 6, 2025
Study Start
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2025
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 6, 2025
Record last verified: 2025-07
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