Evaluating Near-infrared Spectroscopy Devices for Monitoring Traumatic Brain Injury

NCT07106216 | Not Yet Recruiting

• 2 other identifiers: IRAS 330193EP/S022139/1
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

brain; head; injury; severe; nirs

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Severe brain injury

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Addenbookes (Cambridge, UK) neuro critical care ward patients

You may qualify if:

• 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."

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cambridge: lead
• Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Wounds and Injuries; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Peter Smielewski, PhD

  Cambridge University Hospitals

  STUDY DIRECTOR

Central Study Contacts

Cameron Smith, MSc, MRes

CONTACT

01223 748300; cs2159@cam.ac.uk

Gemma Bale, PhD

CONTACT

gmb49@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: August 6, 2025
• Study Start: August 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share