๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-11-19

A Study to Evaluate the SENSE Device's Ability to Detect TBI (NCT06828107)

A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Sense Diagnostics, LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The study population will consist of 3 mutually-exclusive sets of patients and subjects: * TBI patients with intracranial bleeding * TBI patients without intracranial bleeding * Control subjects with normal brain health. Research subjects ages 22 and older will be enrolled. All TBI patients must be monitored with the SENSE Device within 6 hours of a diagnostic head CT scan ordered by a treating clinician and within 24 hours of injury.

Who can join: Review the eligibility criteria below.

Location: University of Florida โ€” Gainesville, Florida

Age range: 22 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (6 Sites)

  • University of Florida โ€” Gainesville, Florida
  • University of Cincinnati โ€” Cincinnati, Ohio
  • University of Pittsburgh โ€” Pittsburgh, Pennsylvania
  • MUSC โ€” Charleston, South Carolina
  • UT Houston โ€” Houston, Texas
  • UTSA โ€” San Antonio, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (513) 309-8325

Email: skeegan@senseneuro.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—