Clinical trial NCT05287997: Blood Biomarker Study to Diagnose Adolescent Sport Concussion
Official title: A 2-Part Capillary Blood Biomarker Cohort Study to Diagnose Adolescent Sport Concussion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Concussion
Lead sponsor: Neurolytixs
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 150
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will enrol into the Baseline Arm of the study. Participants will attend all Baseline Visits unless they experience a concussion at which point, they will transition to the Concussion Arm for further follow-up.
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Part A: Calculate population reference ranges for 10 phosphatidylcholines (PC) specific to Neurolytixs assay kit.
timeFrame: End of Part A (4-6 months)
measure: Part A: Generate Area Under the Curve (AUC) values specific to the Neurolytixs assay kit
timeFrame: End of Part A (4-6 months)
measure: Part B: Determine efficacy of Neurolytixs assay kit for diagnosing adolescent sports concussion
timeFrame: 12-72 hours post-injury
measure: Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion
timeFrame: Through study completion, up to 1 year
measure: Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery
timeFrame: 12 weeks post-injury
Other outcomes:
measure: Part B: Compare proportion of males and females with a change in PC1
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC2
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC3
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC4
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC5
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC6
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC7
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC8
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC9
timeFrame: 12 weeks post-injury
measure: Part B: Compare proportion of males and females with a change in PC10
timeFrame: 12 weeks post-injury
measure: Number of Unanticipated Adverse Device Effects
timeFrame: Through study completion, up to 1 year
Locations:
city: Brighton
country: United States
facility: Legacy Center Sports Complex
state: Michigan
city: Caledon
country: Canada
facility: The Hill Academy
state: Ontario
Study officials:
affiliation: Neurolytixs
name: Douglas D Fraser, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: