Blood Biomarker Study to Diagnose Adolescent Sport Concussion

Neurolytixs

Status: Enrolling

Conditions: Brain Concussion

Treatments: Diagnostic Test: Neurolytixs Index

Study type: Interventional

Funder types: Industry

Identifiers

NCT05287997

NLI01

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Provision of signed and dated informed consent/assent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female athletes, aged 13-17 inclusive

Exclusion criteria

1. Individuals who have suffered a known concussion within the 6 months prior to enrollment
2. Individuals who suffer from an acute neurological disorder
3. Known pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Baseline

Other group

Description:

Participants in this arm will be evaluated at 3 time periods. Initial pre-season visit, mid-season visit and end-of-season visit. Capillary blood sample collection will occur at each visit.

Treatment:

Diagnostic Test: Neurolytixs Index

Concussion

Experimental group

Description:

Participants in this arm will transition from the baseline arm to the concussion arm if they experience a concussion during the course of the sporting season. They will be evaluated with 72 hours of the injury and then at 2-, 4-, and 12-weeks post-injury. Capillary blood sample collection will occur at each visit.

Treatment:

Diagnostic Test: Neurolytixs Index