Study of a Hand-held GFAP Biosensor for Rapid, Accurate Diagnosis and Monitoring of Concussion in Adults

What this Trial Is About

Researchers are evaluating a hand-held biosensor designed to measure a blood biomarker called glial fibrillary acidic protein GFAP in adults with concussion. The study aims to determine if this biosensor can measure GFAP as accurately as the current standard technique and explore whether these measurements relate to psychological and physical symptoms of concussion. The study will compare concussion patients to those with musculoskeletal injuries to see if the biosensors readings are specific to concussion. The study involves recruiting adults aged 18 to 65 who come to the emergency department with either concussion or musculoskeletal injuries. Concussion participants will have blood samples taken and complete questionnaires at their initial visit within 1 week of injury, then again at 2, 6, and 12 weeks after injury. Those not recovered by 12 weeks will also be followed up at 6 months. Musculoskeletal injury participants will complete measures at a single visit. The biosensor readings will be compared with the standard assay technique called SIMOA. Participants provide blood samples and complete various assessments including quality of life, mental health, sleep, and concussion symptoms. Concussion patients will report daily symptoms through an online scale to monitor recovery. Researchers will analyze blood biomarker levels in serum and plasma over time, and assess how these relate to recovery and symptoms. The study includes a follow-up period up to 6 months for some participants to better understand the biosensors clinical performance and recovery patterns.

Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion