Efficacy and Feasibility Trial of a Portable Near Infra-Red Hematoma Imager (NIRD-HI) (NIRD-HI)

January 5, 2026 updated by: The Geneva Foundation

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78234
        • Brooke Army Medical Center
        • Contact:
        • Principal Investigator:
          • Julie Rizzo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: NIRD-HI scan at the time of enrollment
All enrolled patients who meet the study's eligibility criteria will receive one NIRD-HI scan at the time of enrollment.
Diagnostic test: Secondary NIRD-HI scan when a planned repeat CT is performed
For patients requiring a planned repeat CT, a secondary NIRD-HI scan may be performed before the subsequent CT imaging.
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
Diagnostic test: NIRD-HI scan at the time of enrollment
All enrolled patients who meet the study's eligibility criteria will receive one NIRD-HI scan at the time of enrollment.
Diagnostic test: Secondary NIRD-HI scan when a planned repeat CT is performed
For patients requiring a planned repeat CT, a secondary NIRD-HI scan may be performed before the subsequent CT imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Baseline, at time of NIRD-HI testing administered
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.
Enrollment through study completion, an average of 1 year
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.
Near the end of recruitment period, an average of 1 year
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.
Enrollment through study completion, an average of 1 year
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.
Baseline, at time of NIRD-HI testing administered

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance - Time Detection of ICH
Time Frame: Baseline, at time of NIRD-HI testing administered
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.
Baseline, at time of NIRD-HI testing administered
Diagnostic Performance - Operator Performance
Time Frame: Baseline, at time of NIRD-HI testing administered
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.
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
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.
Baseline, at time of NIRD-HI testing administered

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Geneva Foundation

Collaborators

Uniformed Services University of the Health Sciences
Congressionally Directed Medical Research Programs

Investigators

  • Principal Investigator: Julie Rizzo, MD, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

September 29, 2027

Study Completion (Estimated)

September 29, 2027

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2026.013
  • RC240162 (Other Identifier: CDMRP-eBRAP Log Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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