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Not yet recruitingNCT07094230Updated Aug 1, 2025

Combination iSTAT/Alinity and IR Oculography for Head CT Necessity and Recovery Prediction After mTBI

An interventional study of biomarkers analyses in Blood, sponsored by Captain James A. Lovell Federal Health Care Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by Captain James A. Lovell Federal Health Care Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Use of blood biomarkers and eye tracking after traumatic brain injury for recovery timeline prediction

Read the detailed description

Use of blood biomarkers and video IR oculography after mTBI for necessity of head CT scan and recovery timeline prediction

02

Conditions studied

  • Blood

Keywords

  • mTBI
  • biomarkers
  • IR Oculography
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In context

Lead sponsor

This is the only study on the registry with Captain James A. Lovell Federal Health Care Center as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients aged 18-85, Communicative in English language, With clinician-confirmed mTBI (GCS 13-15, ≤24 hours post-injury)

Exclusion criteria

Exclusion Criteria:

Neurological, vestibular, or visual disorders, Significant comorbidities, Prior TBI (\<6 months) Special populations (pregnant, incarcerated, active-duty recruits). Active-duty recruits excluded due to inability to contact them at scheduled intervals for remote follow-up questionnaires.

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05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    blood biomarkers analyses

    blood biomarkers analyses

    Diagnostic Test: biomarkers analyses

Interventions

  • Diagnostic testbiomarkers analyses

    blood analyses

06

What researchers measure

Primary outcomes

  1. blood biomarkers analyses

    Alinity device analyses of GFAP and UCH-L1

    Time frame: same day

07

Study locations

1 site
  • Captain James A. Lovell Federal Health Care Center
    North Chicago, Illinois 60064, United States
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References and documents

Individual participant data

Plan to share: Yes — blood analyses results, IR Oculography results, recovery timelines questionnaires data

Supporting information: Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07094230
Lead sponsor
Captain James A. Lovell Federal Health Care Center
Responsible party
Jim Buskirk PT, DPT, PhD, MS Ed (Co-Investigator, Captain James A. Lovell Federal Health Care Center) — Principal investigator
First posted
Jul 30, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Aug 2026 (estimated)
Completion
Aug 2026 (estimated)
Last update
Aug 1, 2025

Study contacts

Bharathi Swaminathan, MD
Contact
Bharathi.Swaminathan2@va.gov
224-610-4152
James Buskirk, PT, DPT, PhD, MS
study director · Captain James A. Lovell Federal Health Care Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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