Blood Biomarker Study to Diagnose Adolescent Sport Concussion

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Brain Concussion

Clinical Trial Details

NCT number	NCT05287997
Study type	Interventional
Source	Neurolytixs
Contact	Saoirse Cameron, MA
Phone	5198600462
Email	scameron@neurolytixs.com
Status	Recruiting
Phase	N/A
Start date	June 1, 2022
Completion date	December 2023

View Details

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