๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-08-29

Follow-up of MTBI Patients Discharged from the ED Using Standard Clinical Triage Including BrainScope One (NCT04279431)

๐Ÿ”ต Active, Not Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: BrainScope Company, Inc.

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

The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.

Who can join: Review the eligibility criteria below.

Location: Wayne State University - Detroit Receiving Hospital โ€” Detroit, Michigan

Age range: 18 Years to 85 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 (7 Sites)

  • Wayne State University - Detroit Receiving Hospital โ€” Detroit, Michigan
  • Henry Ford Health System โ€” Detroit, Michigan
  • Wayne State University - Sinai Grace Hospital โ€” Detroit, Michigan
  • Beaumont Hospital โ€” Royal Oak, Michigan
  • Beaumont Hospital โ€” Troy, Michigan
  • Washington University - Barnes Jewish Hospital โ€” St Louis, Missouri
  • El Paso Medical Center โ€” El Paso, Texas

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. Review the official NIH record below to find the coordinating site.
  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†—