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

NCT07338383 | Not Yet Recruiting

• 2 other identifiers: C.2026.013RC240162
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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; Combat Casualty Care; Point of Care; Intracranial Hemorrhages

Keywords

Traumatic Brain Injury; Intracranial Hemorrhage; NIRD-HI

Outcome Measures

Primary Outcomes (5)

• 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%.

  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.

  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.

  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.

  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.

  Baseline, at time of NIRD-HI testing administered

Secondary Outcomes (3)

• Diagnostic Performance - Time Detection of ICH

  Baseline, at time of NIRD-HI testing administered

• Diagnostic Performance - Operator Performance

  Baseline, at time of NIRD-HI testing administered

• Accuracy of evolution testing [first NIRD HI scan vs. second NIRD HI]

  Baseline, at time of NIRD-HI testing administered

Study Arms (2)

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; 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

Diagnostic Test: NIRD-HI scan at the time of enrollment; Diagnostic Test: Secondary NIRD-HI scan when a planned repeat CT is performed

Interventions

NIRD-HI scan at the time of enrollment DIAGNOSTIC_TEST

All enrolled patients who meet the study's eligibility criteria will receive one NIRD-HI scan at the time of enrollment.

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 performed DIAGNOSTIC_TEST

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; 40 participants with positive head bleed on CT report

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Presence of penetrating or non-survivable injuries
• Hemorrhagic shock or large volume transfusion \[\>3 units of any blood product within
• hour of scan\]
• 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

Sponsors & Collaborators

• The Geneva Foundation: lead
• Congressionally Directed Medical Research Programs: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (11)

• Taylor CA, Bell JM, Breiding MJ, Xu L. Traumatic Brain Injury-Related Emergency Department Visits, Hospitalizations, and Deaths - United States, 2007 and 2013. MMWR Surveill Summ. 2017 Mar 17;66(9):1-16. doi: 10.15585/mmwr.ss6609a1.

  PMID: 28301451 BACKGROUND

• 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.

  PMID: 32902808 BACKGROUND

• McCredie 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.

  PMID: 33852501 BACKGROUND

• Fletcher-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.

  PMID: 36167951 BACKGROUND

• Tien 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.

  PMID: 21494125 BACKGROUND

• Kainerstorfer 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.

  PMID: 20799809 BACKGROUND

• Robertson 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.

  PMID: 20568959 BACKGROUND

• Gramer 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.

  PMID: 35856820 BACKGROUND

• Riley 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.

  PMID: 22254179 BACKGROUND

• Bell 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.

  PMID: 19359953 BACKGROUND

• Centers 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

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Rizzo, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marisol Resendiz, PhD

CONTACT

210-916-5821; marisol.resendiz.ctr@health.mil

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): September 29, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)