NCT04423198

HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma

HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma II

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: BRAINBox Solutions Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.

Detailed description

This study proposes to collect data using a multi-modality approach including blood biomarkers, clinical assessments, neurocognitive performance, and neuropsychological characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their likelihood of chronic symptoms. This is an observational study with an expectation of enrolling up to 2000 subjects. These subjects will include the intended use population, subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma. Data will be collected across four time points, T=0, 14 days, 30 days and 90 days, to allow for building and validating the algorithms for both diagnosis and prognosis claims. Control populations, healthy and trauma only (no head trauma) will be included for assay development. Data will be collected for these groups at T=0 and 14 days (trauma control only).

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Assessment	Self administered cognitive battery
BEHAVIORAL	Patient Reported Neurological Outcome Assessments	Standard neurocognitive and neuropsychological tests
PROCEDURE	Blood Draw	Specimen collection of whole blood, serum, RNA

Timeline

• Start date: 2020-12-31
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-06-09
• Last updated: 2021-08-04

Locations

11 sites across 1 country: United States