[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601109":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":10,"responsibleParty":26,"collaborators":30,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":10,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"University of Cambridge","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Severe brain injury",null,"Those with severe (as defined by the Glasgow Coma Scale) brain injuries",[13],{"name":14,"affiliation":15,"role":16},"Peter Smielewski, PhD","Cambridge University Hospitals","STUDY_DIRECTOR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":22},"Cameron Smith, MSc, MRes","CONTACT","01223 748300","cs2159@cam.ac.uk",{"name":24,"role":20,"phone":10,"phoneExt":10,"email":25},"Gemma Bale, PhD","gmb49@cam.ac.uk",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Peter J. Hutchinson MD","Professor",[31,34],{"name":32,"class":33},"Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, UK","UNKNOWN",{"name":35,"class":6},"Cambridge University Hospitals NHS Foundation Trust","100601109","evaluating-near-infrared-spectroscopy-devices-for-monitoring-traumatic-brain-injury-100601109",false,"NCT07106216","Evaluating Near-infrared Spectroscopy Devices for Monitoring Traumatic Brain Injury","Evaluating Two Novel Near-infrared Spectroscopy Devices for Non-invasive Monitoring of Traumatic Brain Injury in the Neuro Critical Care Unit.","NIRS in TBI","Inclusion Criteria:\n\nThose in the Neuro Critical Care Unit at Addenbrooke's (Cambridge, UK) AND\n\nPatients with moderate or severe head trauma AND\n\nOver 18 AND\n\nThose with intracranial pressure monitoring probes.\"\n\nExclusion Criteria:\n\nWe will not monitor anyone aged under 18 OR\n\nWe will not monitor anyone with penetrating wounds in the area we want to monitor OR\n\nPatients who are enrolled on \\>2 other research studies, as per local guidelines OR\n\nMoribund at presentation OR\n\nThose with infectious diseases.","ALL","18 Years",{"count":47,"type":48},10,"ESTIMATED","OBSERVATIONAL","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.\n\nParticipants 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.\n\nThe 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.",[52],"Tramatic Brain Injury",[54,55,56,57,58],"brain","head","injury","severe","nirs","NOT_YET_RECRUITING","2025-07-29",{"date":62,"type":63},"2025-08-06","ACTUAL",{"date":65,"type":48},"2025-08-01",{"date":67,"type":48},"2026-09-30",{"name":5,"class":6}]