Traumatic Brain InjuryNIRD-HINCT07338383
Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI)
An observational study of Traumatic Brain Injury and Intracranial Hemorrhages, run by The Geneva Foundation at 1 site in United States.
Trial summary
Traumatic Brain Injury (TBI) is a leading cause of death and disability among military personnel, Veterans, and civilians. One of the most dangerous complications of moderate-to-severe TBI is intracranial hemorrhage (ICH). Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hemorrhages, Combat Casualty Care
- What is being tested?
- NIRD-HI scan at the time of enrollment and Secondary NIRD-HI scan when a planned repeat CT is performed
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 29 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Access to the proposed population includes a mixture of 15% active-duty military and/or VA patients and 85% civilians from central/southern Texas, including the 22 surrounding counties that are receiving trauma care at Brooke Army Medical Center. Daily review of the Trauma census will be conducted to review eligible patients. This screening tool will help determine, predict, and address challenges to recruitment.
Who may be able to join
- 18 to 89 years of age
- Able to provide written informed consent either by self or legally authorized representative
- Received head CT imaging on admission
- Able to complete at least one NIRD-HI scan within 4 hours of head CT
- Non-operative management planned
Who cannot join
- Presence of penetrating or non-survivable injuries
- Hemorrhagic shock or large volume transfusion [>3 units of any blood product within
- 1 hour of scan]
- Large open skull wounds, scalp lacerations or surface hematomas prohibiting safe or comfortable sensor placement
- Presence of heat tattoos or intracranial metal fixtures
- Cervical injury prolonging C-spine collar
- Known prisoners or wards of state
- Any condition or finding that makes the patient unsuitable for image acquisition in the Investigator's opinion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78234
Marisol Resendiz, PhD, 210-916-5821, marisol.resendiz.ctr@health.mil
Julie Rizzo, MD
About this study
Official title: An Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager for Detection of Intracranial Hemorrhage in the Acute Care Setting
Traumatic Brain Injury (TBI) is a leading cause of death and disability among military personnel, Veterans, and civilians. One of the most dangerous complications of moderate-to-severe TBI is intracranial hemorrhage (ICH). If not identified and treated promptly, ICH can rapidly lead to worsening neurological damage or death. Current diagnostic tools, such as CT scans, are highly effective but impractical for battlefield or resource-limited environments due to their large size and infrastructure dependency.
The Near-Infrared Detection-Head Imaging (NIRD-HI) system is an innovative, noninvasive device using Near-Infrared Spectroscopy (NIRS) to identify abnormal blood accumulation. Unlike traditional tools, NIRD-HI is compact, lightweight, and portable, making it suitable for remote or austere settings. By dynamically imaging the brain, it generates 3D visualizations that pinpoint the size and location of bleeds, including complex bilateral injuries. This offers a significant improvement over current point-of-injury technologies that lack the resolution to reliably diagnose all forms of ICH.
Read more
This study supports the FY24 Combat Readiness Medical Research Program by advancing battlefield diagnostic and triage capabilities. The research will:
- Evaluate NIRD-HI's accuracy compared to CT imaging.
- Assess feasibility in real-world acute care settings.
- Investigate its ability to monitor changes in ICH over time.
These objectives address the military's need for tools that improve rapid diagnosis and decision-making during emergencies. Implementing this research can revolutionize TBI management. For Service Members, NIRD-HI promises a field-ready solution for early detection, enabling faster intervention and more effective triage. By reducing diagnostic delays, it could save lives and prevent long-term complications. Furthermore, the system supports prolonged field care by providing continuous monitoring of evolving injuries.
The benefits extend to civilian healthcare, particularly in rural or underserved areas lacking advanced imaging. This accessibility can improve trauma care outcomes for millions, reduce the burden on healthcare systems, and provide equitable distribution of life-saving technology. By addressing gaps in battlefield medicine, this project aims to enhance medical readiness and improve survivability in the most challenging environments.
Read the detailed description
Traumatic Brain Injury [TBI] has become the hallmark injury of modern warfare and remains one of the most challenging conditions to diagnose in forward-deployed care settings. One of the primary obstacles in diagnosing TBI on the battlefield is the "silent" or delayed onset of neurological symptoms, which can mask the severity of the injury. A key contributor to poor outcomes in moderate to severe TBI is the presence of acute intracranial bleeding, which can swell rapidly, leading to secondary brain damage or death. Early identification of such bleeds is critical for improving patient survival and neurological recovery.
Currently, CT is the gold standard for diagnosing intracranial hemorrhage [ICH], providing the accuracy needed to detect and evaluate brain bleeds. However, the logistical requirements of CT imaging pose significant challenges in deployed or resource-limited environments. These demands render CT impractical for field use, leaving forward-operating medical personnel without a reliable imaging solution for rapid TBI diagnosis. Consequently, there is a pressing need for portable, point-of-injury [POI] diagnostic tools that can effectively detect brain injuries in austere settings.
In both military and civilian contexts, there is an unmet need for a diagnostic device that can alert medical personnel to changes in ICH status without relying on resource-intensive serial imaging or neurological monitoring. Such a tool could enable timely triage and inform critical medical evacuation decisions, improving outcomes for patients with TBI. Existing POI technologies, however, predominantly rely on functional assessments and indirect measures of TBI, which are inherently subjective and often lack specificity. The reliance on such methods can result in false positives or negatives, particularly in low-incidence injuries, where positive predictive value [PPV] tends to fall below 50%. In military medicine, ensuring high sensitivity and specificity is crucial, as initiating unnecessary treatment or evacuations can impose significant operational risks and resource costs. A field-ready diagnostic tool capable of accurately identifying ICH and other TBI complications is therefore essential for improving care in both military and civilian emergency settings.
Existing POI technologies, however, predominantly rely on functional assessments and indirect measures of TBI, which are inherently subjective and often lack specificity. The reliance on such methods can result in false positives or negatives, particularly in low-incidence injuries, where positive predictive value [PPV] tends to fall below 50%. In military medicine, ensuring high sensitivity and specificity is crucial, as initiating unnecessary treatment or evacuations can impose significant operational risks and resource costs. A field-ready diagnostic tool capable of accurately identifying ICH and other TBI complications is therefore essential for improving care in both military and civilian emergency settings.
Near-Infrared Spectroscopy [NIRS] can be used to interrogate tissue. It has been well studied over the years and it can be shown that the principal components of variation in intensity response from tissue can be ascribed to blood volume and oxygenation. The reflected light from the NIR source is used to determine the presence of blood volume in the tissue beneath the sensor. By comparing tissues from different locations within the brain the presence of large volumes of blood that represent a pathological event can be detected. The use of near infra-red [NIR] to estimate the presence of intracranial bleeding spectroscopically has been previously demonstrated, with high agreement with traditional head CT. Though effective for detection of a statichemorrhagic event, there are no currently available NIR-based technology that employs dynamic structural imaging. Moreover, current tools cannot reliably diagnose all types of hematomas, particularly bilateral head injuries.
IMPACT AND RELEVANCE. Approximately 60% of wounded soldiers sustain blast injuries and two-thirds are diagnosed with a TBI. While the majority of TBIs are mild and nonfatal, 17-20% of severe TBI patients die within the first 24 hours after injury underscoring the importance of rapid assessment and accurate triage. Of those who survive the acute phase of a TBI, up to 57% experience chronic health problems related to their injury. This translates to a great economic burden and severe reduction of quality of life for millions of Service Members, Veterans, and civilians. Demonstration of a rapid triage tool for ICH resulting from TBI may expedite diagnosis and treatment, which could minimize the adverse consequences of TBI. Alternatively, the device could rule out injuries for which medical evacuation is non-emergent, preserving Force resources. Advancement of POI diagnostic tools hinges on the demonstration of the efficacy and feasibility of the tool in the acute care setting. In alignment with the goals of conducting high impact translational research that will accelerate innovative ideas into clinical applications that are relevant to Service Members, Veterans, and their families, this study aims to provide critical performance evaluation for the NIRD HI in a US population of TBI patients. Although this study will be conducted in level I trauma center, the questions addressed are applicable to military practice, prolonged field care in particular. Current Joint Trauma System Clinical Practice Guideline [JTS CPG)] for TBI management in prolonged field care [CPG ID: 63] rely on specialized assessments and/or equipment to detect raised intracranial pressure resulting from an ICH. Earlier detection of an intracranial bleed, prior to clinical deterioration, could change triage priorities and inform medical evacuation plans, key to decreasing mortality and improving functional outcomes and quality of life.
- Being tested
- NIRD-HI scan at the time of enrollment, Secondary NIRD-HI scan when a planned repeat CT is performed
- Keywords
- Traumatic Brain Injury, Intracranial Hemorrhage, NIRD-HI
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRD-HI scan at the time of enrollmentDiagnostic test
All enrolled patients who meet the study's eligibility criteria will receive one NIRD-HI scan at the time of enrollment.
Secondary NIRD-HI scan when a planned repeat CT is performedDiagnostic test
For patients requiring a planned repeat CT, a secondary NIRD-HI scan may be performed before the subsequent CT imaging.
| Study group | Role | What they receive |
|---|---|---|
| 40 participants with positive head bleed on CT report | Subjects with positive head CT reports that may have a diagnosis of TBI or intracranial hemorrhage Receives: Diagnostic Test: NIRD-HI scan at the time of enrollment; Diagnostic Test: Secondary NIRD-HI scan when a planned repeat CT is performed | |
| 40 participants with negative head bleed on CT report | Subjects without positive head CT reports that may have a diagnosis of TBI or intracranial hemorrhage Receives: Diagnostic Test: NIRD-HI scan at the time of enrollment; Diagnostic Test: Secondary NIRD-HI scan when a planned repeat CT is performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance
Diagnostic Performance. Establish the sensitivity, specificity, PPV, and NPV of the NIRD-HI system for detecting ICH in TBI patients, with a target sensitivity and specificity exceeding 90%.
Measured: Baseline, at time of NIRD-HI testing administered
Feasibility Assessment - Scan Time
Time in minutes to complete scans in acute care setting recorded on a templated study log including scan start/stop time, interruptions and reasons for interruptions, technical errors and unanticipated device adverse events.
Measured: Enrollment through study completion, an average of 1 year
Feasibility Assessment - Operator Usability
Operator usability near the end of the recruitment period, 4-6 blinded clinicians (physicians and/or mid-level practritioners) will make a determination of criteria positive or negative research scans assigned in random order to establish statistics for inter-reader agreement. Blinded readers will assign a likelihood score using a Visual Analog Scale [VAS] to indicate how confident they are in their read.
Measured: Near the end of recruitment period, an average of 1 year
Feasibility Assessment - Device Integration
Device integration, through operator feedback questionnaire regarding ease of use.
Measured: Enrollment through study completion, an average of 1 year
Monitoring of ICH Progression
NIRD-HI readouts for the presence/absence of ICH and region of detection [if positive] as determined by the research device. NIRD-HI readouts will be correlated with Head CT results after each scan.
Measured: Baseline, at time of NIRD-HI testing administered
Secondary outcomes (3)
Diagnostic Performance - Time Detection of ICH
Start/stop times of NIRD-HI readouts will be correlated with Head CT results after each scan for accuracy and start/stop times of scans.
Measured: Baseline, at time of NIRD-HI testing administered
Diagnostic Performance - Operator Performance
Ability to perform NIRD-HI scans [i] scans not performed for subjectreasons [e.g. wounds, bandages, c-spine protection]; [ii] scans not performed for operator reasons [e.g. inability to use device correctly); [iii] scans not performed because of technical issues with the device; and [c] inter-reader agreement.
Measured: Baseline, at time of NIRD-HI testing administered
Accuracy of evolution testing [first NIRD HI scan vs. second NIRD HI]
A subset of subjects with available follow-up head CT will be compared to changes confirmed by CT imaging, to evaluate the efficacy of the device for monitoring intracranial hemorrhages.
Measured: Baseline, at time of NIRD-HI testing administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion29 Sep 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Geneva Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Julie Rizzo, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338383
- Sponsor's protocol ID
- C.2026.013
- Other IDs
- RC240162
- Acronym
- NIRD-HI
- Status last verified
- Jan 2026
- First submitted
- 3 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD data will not be shared
Publications
Peterson, Alexis B. et al. (2019). Surveillance report of traumatic brain injury-related emergency department visits, hospitalizations, and deaths, United States, 2014. Available from: www.cdc.gov/traumaticbraininjury/get_the_facts.html
Law ZK, Dineen R, England TJ, Cala L, Mistri AK, Appleton JP, Ozturk S, Bereczki D, Ciccone A, Bath PM, Sprigg N; TICH-2 investigators. Predictors and Outcomes of Neurological Deterioration in Intracerebral Hemorrhage: Results from the TICH-2 Randomized Controlled Trial. Transl Stroke Res. 2021 Apr;12(2):275-283. doi: 10.1007/s12975-020-00845-6. Epub 2020 Sep 9.
PubMed 32902808McCredie VA, Chavarria J, Baker AJ. How do we identify the crashing traumatic brain injury patient - the intensivist's view. Curr Opin Crit Care. 2021 Jun 1;27(3):320-327. doi: 10.1097/MCC.0000000000000825.
PubMed 33852501Fletcher-Sandersjoo A, Tatter C, Tjerkaski J, Bartek J Jr, Maegele M, Nelson DW, Svensson M, Thelin EP, Bellander BM. Time Course and Clinical Significance of Hematoma Expansion in Moderate-to-Severe Traumatic Brain Injury: An Observational Cohort Study. Neurocrit Care. 2023 Feb;38(1):60-70. doi: 10.1007/s12028-022-01609-w. Epub 2022 Sep 27.
PubMed 36167951Tien HC, Jung V, Pinto R, Mainprize T, Scales DC, Rizoli SB. Reducing time-to-treatment decreases mortality of trauma patients with acute subdural hematoma. Ann Surg. 2011 Jun;253(6):1178-83. doi: 10.1097/SLA.0b013e318217e339.
PubMed 21494125Kainerstorfer JM, Ehler M, Amyot F, Hassan M, Demos SG, Chernomordik V, Hitzenberger CK, Gandjbakhche AH, Riley JD. Principal component model of multispectral data for near real-time skin chromophore mapping. J Biomed Opt. 2010 Jul-Aug;15(4):046007. doi: 10.1117/1.3463010.
PubMed 20799809Robertson CS, Zager EL, Narayan RK, Handly N, Sharma A, Hanley DF, Garza H, Maloney-Wilensky E, Plaum JM, Koenig CH, Johnson A, Morgan T. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. J Neurotrauma. 2010 Sep;27(9):1597-604. doi: 10.1089/neu.2010.1340.
PubMed 20568959Gramer R, Shlobin NA, Yang Z, Niedzwiecki D, Haglund MM, Fuller AT. Clinical Utility of Near-Infrared Device in Detecting Traumatic Intracranial Hemorrhage: A Pilot Study Toward Application as an Emergent Diagnostic Modality in a Low-Resource Setting. J Neurotrauma. 2023 Aug;40(15-16):1596-1602. doi: 10.1089/neu.2021.0342. Epub 2022 Aug 2.
PubMed 35856820Riley JD, Amyot F, Pohida T, Pursley R, Ardeshirpour Y, Kainerstorfer JM, Najafizadeh L, Chernomordik V, Smith P, Smirniotopoulos J, Wassermann EM, Gandjbakhche AH. A hematoma detector-a practical application of instrumental motion as signal in near infra-red imaging. Biomed Opt Express. 2012 Jan 1;3(1):192-205. doi: 10.1364/BOE.3.000192. Epub 2011 Dec 20.
PubMed 22254179Bell RS, Vo AH, Neal CJ, Tigno J, Roberts R, Mossop C, Dunne JR, Armonda RA. Military traumatic brain and spinal column injury: a 5-year study of the impact blast and other military grade weaponry on the central nervous system. J Trauma. 2009 Apr;66(4 Suppl):S104-11. doi: 10.1097/TA.0b013e31819d88c8.
PubMed 19359953Centers for Disease Control and Prevention, National Center for Injury Prevention and Control. Report to Congress on traumatic brain injury in the United States: Epidemiology and rehabilitation. Atlanta (GA): Centers for Disease Control and Prevention; 2015
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager for Detection of Intracranial Hemorrhage in the Acute Care Setting
- ClinicalTrials.gov ID
- NCT07338383
- Acronym / sponsor ID
- NIRD-HI / C.2026.013
- Keywords
- Traumatic Brain Injury, Intracranial Hemorrhage, NIRD-HI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Geneva FoundationUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, Uniformed Services University of the Health Sciences
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traumatic Brain Injury (TBI) is a leading cause of death and disability among military personnel, Veterans, and civilians. One of the most dangerous complications of moderate-to-severe TBI is intracranial hemorrhage (ICH). If not identified and treated promptly, ICH can rapidly lead to worsening neurological damage or death. Current diagnostic tools, such as CT scans, are highly effective but impractical for battlefield or resource-limited environments due to their large size and infrastructure dependency.
The Near-Infrared Detection-Head Imaging (NIRD-HI) system is an innovative, noninvasive device using Near-Infrared Spectroscopy (NIRS) to identify abnormal blood accumulation. Unlike traditional tools, NIRD-HI is compact, lightweight, and portable, making it suitable for remote or austere settings. By dynamically imaging the brain, it generates 3D visualizations that pinpoint the size and location of bleeds, including complex bilateral injuries. This offers a significant improvement over current point-of-injury technologies that lack the resolution to reliably diagnose all forms of ICH.
This study supports the FY24 Combat Readiness Medical Research Program by advancing battlefield diagnostic and triage capabilities. The research will:
- Evaluate NIRD-HI's accuracy compared to CT imaging.
- Assess feasibility in real-world acute care settings.
- Investigate its ability to monitor changes in ICH over time.
These objectives address the military's need for tools that improve rapid diagnosis and decision-making during emergencies. Implementing this research can revolutionize TBI management. For Service Members, NIRD-HI promises a field-ready solution for early detection, enabling faster intervention and more effective triage. By reducing diagnostic delays, it could save lives and prevent long-term complications. Furthermore, the system supports prolonged field care by providing continuous monitoring of evolving injuries.
The benefits extend to civilian healthcare, particularly in rural or underserved areas lacking advanced imaging. This accessibility can improve trauma care outcomes for millions, reduce the burden on healthcare systems, and provide equitable distribution of life-saving technology. By addressing gaps in battlefield medicine, this project aims to enhance medical readiness and improve survivability in the most challenging environments.
Detailed description
Traumatic Brain Injury [TBI] has become the hallmark injury of modern warfare and remains one of the most challenging conditions to diagnose in forward-deployed care settings. One of the primary obstacles in diagnosing TBI on the battlefield is the "silent" or delayed onset of neurological symptoms, which can mask the severity of the injury. A key contributor to poor outcomes in moderate to severe TBI is the presence of acute intracranial bleeding, which can swell rapidly, leading to secondary brain damage or death. Early identification of such bleeds is critical for improving patient survival and neurological recovery.
Currently, CT is the gold standard for diagnosing intracranial hemorrhage [ICH], providing the accuracy needed to detect and evaluate brain bleeds. However, the logistical requirements of CT imaging pose significant challenges in deployed or resource-limited environments. These demands render CT impractical for field use, leaving forward-operating medical personnel without a reliable imaging solution for rapid TBI diagnosis. Consequently, there is a pressing need for portable, point-of-injury [POI] diagnostic tools that can effectively detect brain injuries in austere settings.
In both military and civilian contexts, there is an unmet need for a diagnostic device that can alert medical personnel to changes in ICH status without relying on resource-intensive serial imaging or neurological monitoring. Such a tool could enable timely triage and inform critical medical evacuation decisions, improving outcomes for patients with TBI. Existing POI technologies, however, predominantly rely on functional assessments and indirect measures of TBI, which are inherently subjective and often lack specificity. The reliance on such methods can result in false positives or negatives, particularly in low-incidence injuries, where positive predictive value [PPV] tends to fall below 50%. In military medicine, ensuring high sensitivity and specificity is crucial, as initiating unnecessary treatment or evacuations can impose significant operational risks and resource costs. A field-ready diagnostic tool capable of accurately identifying ICH and other TBI complications is therefore essential for improving care in both military and civilian emergency settings.
Existing POI technologies, however, predominantly rely on functional assessments and indirect measures of TBI, which are inherently subjective and often lack specificity. The reliance on such methods can result in false positives or negatives, particularly in low-incidence injuries, where positive predictive value [PPV] tends to fall below 50%. In military medicine, ensuring high sensitivity and specificity is crucial, as initiating unnecessary treatment or evacuations can impose significant operational risks and resource costs. A field-ready diagnostic tool capable of accurately identifying ICH and other TBI complications is therefore essential for improving care in both military and civilian emergency settings.
Near-Infrared Spectroscopy [NIRS] can be used to interrogate tissue. It has been well studied over the years and it can be shown that the principal components of variation in intensity response from tissue can be ascribed to blood volume and oxygenation. The reflected light from the NIR source is used to determine the presence of blood volume in the tissue beneath the sensor. By comparing tissues from different locations within the brain the presence of large volumes of blood that represent a pathological event can be detected. The use of near infra-red [NIR] to estimate the presence of intracranial bleeding spectroscopically has been previously demonstrated, with high agreement with traditional head CT. Though effective for detection of a statichemorrhagic event, there are no currently available NIR-based technology that employs dynamic structural imaging. Moreover, current tools cannot reliably diagnose all types of hematomas, particularly bilateral head injuries.
IMPACT AND RELEVANCE. Approximately 60% of wounded soldiers sustain blast injuries and two-thirds are diagnosed with a TBI. While the majority of TBIs are mild and nonfatal, 17-20% of severe TBI patients die within the first 24 hours after injury underscoring the importance of rapid assessment and accurate triage. Of those who survive the acute phase of a TBI, up to 57% experience chronic health problems related to their injury. This translates to a great economic burden and severe reduction of quality of life for millions of Service Members, Veterans, and civilians. Demonstration of a rapid triage tool for ICH resulting from TBI may expedite diagnosis and treatment, which could minimize the adverse consequences of TBI. Alternatively, the device could rule out injuries for which medical evacuation is non-emergent, preserving Force resources. Advancement of POI diagnostic tools hinges on the demonstration of the efficacy and feasibility of the tool in the acute care setting. In alignment with the goals of conducting high impact translational research that will accelerate innovative ideas into clinical applications that are relevant to Service Members, Veterans, and their families, this study aims to provide critical performance evaluation for the NIRD HI in a US population of TBI patients. Although this study will be conducted in level I trauma center, the questions addressed are applicable to military practice, prolonged field care in particular. Current Joint Trauma System Clinical Practice Guideline [JTS CPG)] for TBI management in prolonged field care [CPG ID: 63] rely on specialized assessments and/or equipment to detect raised intracranial pressure resulting from an ICH. Earlier detection of an intracranial bleed, prior to clinical deterioration, could change triage priorities and inform medical evacuation plans, key to decreasing mortality and improving functional outcomes and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 participants with positive head bleed on CT report | – | Diagnostic Test: NIRD-HI scan at the time of enrollment, Diagnostic Test: Secondary NIRD-HI scan when a planned repeat CT is performedSubjects with positive head CT reports that may have a diagnosis of TBI or intracranial hemorrhage |
| 40 participants with negative head bleed on CT report | – | Diagnostic Test: NIRD-HI scan at the time of enrollment, Diagnostic Test: Secondary NIRD-HI scan when a planned repeat CT is performedSubjects without positive head CT reports that may have a diagnosis of TBI or intracranial hemorrhage |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Access to the proposed population includes a mixture of 15% active-duty military and/or VA patients and 85% civilians from central/southern Texas, including the 22 surrounding counties that are receiving trauma care at Brooke Army Medical Center. Daily review of the Trauma census will be conducted to review eligible patients. This screening tool will help determine, predict, and address challenges to recruitment.
Key inclusion criteria (5 listed)
- 18 to 89 years of age
- Able to provide written informed consent either by self or legally authorized representative
- Received head CT imaging on admission
- Able to complete at least one NIRD-HI scan within 4 hours of head CT
- Non-operative management planned
Key exclusion criteria (8 listed)
- Presence of penetrating or non-survivable injuries
- Hemorrhagic shock or large volume transfusion [>3 units of any blood product within
- 1 hour of scan]
- Large open skull wounds, scalp lacerations or surface hematomas prohibiting safe or comfortable sensor placement
- Presence of heat tattoos or intracranial metal fixtures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRD-HI scan at the time of enrollmentAll enrolled patients who meet the study's eligibility criteria will receive one NIRD-HI scan at the time of enrollment. | Diagnostic test | 40 participants with negative head bleed on CT report, 40 participants with positive head bleed on CT report |
| Secondary NIRD-HI scan when a planned repeat CT is performedFor patients requiring a planned repeat CT, a secondary NIRD-HI scan may be performed before the subsequent CT imaging. | Diagnostic test | 40 participants with negative head bleed on CT report, 40 participants with positive head bleed on CT report |
Primary outcome
Diagnostic Performance
Time frame: Baseline, at time of NIRD-HI testing administered
Diagnostic Performance. Establish the sensitivity, specificity, PPV, and NPV of the NIRD-HI system for detecting ICH in TBI patients, with a target sensitivity and specificity exceeding 90%.
Feasibility Assessment - Scan Time
Time frame: Enrollment through study completion, an average of 1 year
Time in minutes to complete scans in acute care setting recorded on a templated study log including scan start/stop time, interruptions and reasons for interruptions, technical errors and unanticipated device adverse events.
Feasibility Assessment - Operator Usability
Time frame: Near the end of recruitment period, an average of 1 year
Operator usability near the end of the recruitment period, 4-6 blinded clinicians (physicians and/or mid-level practritioners) will make a determination of criteria positive or negative research scans assigned in random order to establish statistics for inter-reader agreement. Blinded readers will assign a likelihood score using a Visual Analog Scale [VAS] to indicate how confident they are in their read.
Feasibility Assessment - Device Integration
Time frame: Enrollment through study completion, an average of 1 year
Device integration, through operator feedback questionnaire regarding ease of use.
Monitoring of ICH Progression
Time frame: Baseline, at time of NIRD-HI testing administered
NIRD-HI readouts for the presence/absence of ICH and region of detection [if positive] as determined by the research device. NIRD-HI readouts will be correlated with Head CT results after each scan.
3 secondary outcomes
Diagnostic Performance - Time Detection of ICH
Time frame: Baseline, at time of NIRD-HI testing administered
Diagnostic Performance - Operator Performance
Time frame: Baseline, at time of NIRD-HI testing administered
Accuracy of evolution testing [first NIRD HI scan vs. second NIRD HI]
Time frame: Baseline, at time of NIRD-HI testing administered
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- BackgroundPeterson, Alexis B. et al. (2019). Surveillance report of traumatic brain injury-related emergency department visits, hospitalizations, and deaths, United States, 2014. Available from: www.cdc.gov/traumaticbraininjury/get_the_facts.html
- Background: PubMed 32902808Law ZK, Dineen R, England TJ, Cala L, Mistri AK, Appleton JP, Ozturk S, Bereczki D, Ciccone A, Bath PM, Sprigg N; TICH-2 investigators. Predictors and Outcomes of Neurological Deterioration in Intracerebral Hemorrhage: Results from the TICH-2 Randomized Controlled Trial. Transl Stroke Res. 2021 Apr;12(2):275-283. doi: 10.1007/s12975-020-00845-6. Epub 2020 Sep 9.
- Background: PubMed 33852501McCredie VA, Chavarria J, Baker AJ. How do we identify the crashing traumatic brain injury patient - the intensivist's view. Curr Opin Crit Care. 2021 Jun 1;27(3):320-327. doi: 10.1097/MCC.0000000000000825.
- Background: PubMed 36167951Fletcher-Sandersjoo A, Tatter C, Tjerkaski J, Bartek J Jr, Maegele M, Nelson DW, Svensson M, Thelin EP, Bellander BM. Time Course and Clinical Significance of Hematoma Expansion in Moderate-to-Severe Traumatic Brain Injury: An Observational Cohort Study. Neurocrit Care. 2023 Feb;38(1):60-70. doi: 10.1007/s12028-022-01609-w. Epub 2022 Sep 27.
- Background: PubMed 21494125Tien HC, Jung V, Pinto R, Mainprize T, Scales DC, Rizoli SB. Reducing time-to-treatment decreases mortality of trauma patients with acute subdural hematoma. Ann Surg. 2011 Jun;253(6):1178-83. doi: 10.1097/SLA.0b013e318217e339.
- Background: PubMed 20799809Kainerstorfer JM, Ehler M, Amyot F, Hassan M, Demos SG, Chernomordik V, Hitzenberger CK, Gandjbakhche AH, Riley JD. Principal component model of multispectral data for near real-time skin chromophore mapping. J Biomed Opt. 2010 Jul-Aug;15(4):046007. doi: 10.1117/1.3463010.
- Background: PubMed 20568959Robertson CS, Zager EL, Narayan RK, Handly N, Sharma A, Hanley DF, Garza H, Maloney-Wilensky E, Plaum JM, Koenig CH, Johnson A, Morgan T. Clinical evaluation of a portable near-infrared device for detection of traumatic intracranial hematomas. J Neurotrauma. 2010 Sep;27(9):1597-604. doi: 10.1089/neu.2010.1340.
- Background: PubMed 35856820Gramer R, Shlobin NA, Yang Z, Niedzwiecki D, Haglund MM, Fuller AT. Clinical Utility of Near-Infrared Device in Detecting Traumatic Intracranial Hemorrhage: A Pilot Study Toward Application as an Emergent Diagnostic Modality in a Low-Resource Setting. J Neurotrauma. 2023 Aug;40(15-16):1596-1602. doi: 10.1089/neu.2021.0342. Epub 2022 Aug 2.
- Background: PubMed 22254179Riley JD, Amyot F, Pohida T, Pursley R, Ardeshirpour Y, Kainerstorfer JM, Najafizadeh L, Chernomordik V, Smith P, Smirniotopoulos J, Wassermann EM, Gandjbakhche AH. A hematoma detector-a practical application of instrumental motion as signal in near infra-red imaging. Biomed Opt Express. 2012 Jan 1;3(1):192-205. doi: 10.1364/BOE.3.000192. Epub 2011 Dec 20.
- Background: PubMed 19359953Bell RS, Vo AH, Neal CJ, Tigno J, Roberts R, Mossop C, Dunne JR, Armonda RA. Military traumatic brain and spinal column injury: a 5-year study of the impact blast and other military grade weaponry on the central nervous system. J Trauma. 2009 Apr;66(4 Suppl):S104-11. doi: 10.1097/TA.0b013e31819d88c8.
- BackgroundCenters for Disease Control and Prevention, National Center for Injury Prevention and Control. Report to Congress on traumatic brain injury in the United States: Epidemiology and rehabilitation. Atlanta (GA): Centers for Disease Control and Prevention; 2015
- Individual participant dataSharing planned: No. IPD data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Rizzo, MD principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Intracranial Hemorrhages, run by The Geneva Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marisol Resendiz, PhD (210-916-5821, marisol.resendiz.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance (time frame: Baseline, at time of NIRD-HI testing administered). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07338383, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.