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

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). 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.

Conditions

• Traumatic Brain Injury
• Intracranial Hemorrhages
• Combat Casualty Care
• Point of Care

Interventions

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.

Sponsors & Collaborators

• Congressionally Directed Medical Research Programs

  collaborator FED

• Uniformed Services University of the Health Sciences

  collaborator FED

• The Geneva Foundation

  lead OTHER

Principal Investigators

• Julie Rizzo, MD · Brooke Army Medical Center

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-09-29

Completion

2027-09-29

Countries

• United States

Study Locations