Blood Biomarker Study to Diagnose Adolescent Sport Concussion
- Conditions
- Brain Concussion
- Interventions
- Diagnostic Test: Neurolytixs Index
- Registration Number
- NCT05287997
- Lead Sponsor
- Neurolytixs
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Provision of signed and dated informed consent/assent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female athletes, aged 13-17 inclusive
- Individuals who have suffered a known concussion within the 6 months prior to enrollment
- Individuals who suffer from an acute neurological disorder
- Known pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Concussion Neurolytixs Index 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. Baseline Neurolytixs Index 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.
- Primary Outcome Measures
Name Time Method Part B: Determine efficacy of Neurolytixs assay kit for diagnosing adolescent sports concussion 12-72 hours post-injury The change of at least 1 PC below the cutoff threshold (determined in Part A)
Part B: Determine safety of the Neurolytixs assay kit for adolescent sports concussion Through study completion, up to 1 year Calculate the number of false positives identified by the assay
Part A: Calculate population reference ranges for 10 phosphatidylcholines (PC) specific to Neurolytixs assay kit. End of Part A (4-6 months) 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.
Part A: Generate Area Under the Curve (AUC) values specific to the Neurolytixs assay kit End of Part A (4-6 months) Generate AUC values for 10 phosphatidylcholines (PCs) for use in Part B
- Secondary Outcome Measures
Name Time Method Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery 12 weeks post-injury Sensitivity and specificity of the assay compared to diagnosis via the SCAT5
Trial Locations
- Locations (2)
Legacy Center Sports Complex
🇺🇸Brighton, Michigan, United States
The Hill Academy
🇨🇦Caledon, Ontario, Canada