Blood Biomarker Study to Diagnose Adolescent Sport Concussion

Neurolytixs150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Brain Concussion

Interventions

Eligibility

Sex: ALLMin age: 13 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Part A: Calculate population reference ranges for 10 phosphatidylcholines (PC) specific to Neurolytixs assay kit.

Population reference values will be determined with the standard definition of a reference range as the interval between which 95% of values of a reference population fall into, in such a way that 2.5% of the time a value will be less than the lower limit of this interval, and 2.5% of the time it will be larger than the upper limit of this interval, whatever the distribution of these values. Measured PC values will be plotted against both sex and the age of participants to which the PCs were measured.

Time frame: End of Part A (4-6 months)

Part A: Generate Area Under the Curve (AUC) values specific to the Neurolytixs assay kit

Generate AUC values for 10 phosphatidylcholines (PCs) for use in Part B

Time frame: End of Part A (4-6 months)

Part B: Determine efficacy of Neurolytixs assay kit for diagnosing adolescent sports concussion

The change of at least 1 PC below the cutoff threshold (determined in Part A)

Time frame: 12-72 hours post-injury

Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion

Calculate the number of false negatives (concussions that are not captured by the assay

Time frame: Through study completion, up to 1 year

Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion

Calculate the number of false positives identified by the assay

Time frame: Through study completion, up to 1 year

Secondary Outcomes

Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery

Sensitivity and specificity of the assay compared to diagnosis via the SCAT5

Time frame: 12 weeks post-injury