NCT05287997

Blood Biomarker Study to Diagnose Adolescent Sport Concussion

A 2-Part Capillary Blood Biomarker Cohort Study to Diagnose Adolescent Sport Concussion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Neurolytixs · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Accepted

Summary

Concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. There is currently no objective measurement for concussion and the reliance on subjective reporting and clinical judgement is imperfect. In previous clinical studies the investigators determined cutoff values of plasma phosphatidylcholines that provided strong indication that a concussion had occurred. Based on this data, the investigators have developed a custom assay, which will work together with a capillary blood collection device. The current clinical trial will be conducted in two parts. Part A will allow the investigators to determine precise AUC cut-off values for the propriety, novel custom assay, and in Part B the investigators will assess the safety and efficacy of this device for concussion diagnosis in adolescent athletes aged 13-17.

Conditions

• Brain Concussion

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Neurolytixs Index	Capillary blood sample will be collected on a dried plasma sample (DPS) filter paper. The sample will be sent to a central laboratory where they will undergo metabolite extraction and analysis via mass spectrometry.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2022-03-18
• Last updated: 2023-04-04

Locations

2 sites across 2 countries: United States, Canada