Blood Biomarker Study to Diagnose Adolescent Sport Concussion

A 2-Part Capillary Blood Biomarker Cohort Study to Diagnose Adolescent Sport Concussion

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 Overview

• Status: Recruiting
• Conditions: Brain Concussion
• Intervention / Treatment: Diagnostic test: Neurolytixs Index

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Caledon, Ontario, Canada, L7K 1S7
      • Recruiting
      • The Hill Academy
      • Contact: Jennifer Bell
• United States
  • Michigan
    • Brighton, Michigan, United States, 48116
      • Recruiting
      • Legacy Center Sports Complex
      • Contact: Cori Crocker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Baseline; 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.	Diagnostic test: Neurolytixs Index; Capillary blood sample will be collected on a dried plasma sample (DPS) filter paper. The sample will be sent to a central laboratory where they will undergo metabolite extraction and analysis via mass spectrometry.
Experimental: Concussion; 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.	Diagnostic test: Neurolytixs Index; Capillary blood sample will be collected on a dried plasma sample (DPS) filter paper. The sample will be sent to a central laboratory where they will undergo metabolite extraction and analysis via mass spectrometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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	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	Through study completion, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks post-injury

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: Compare proportion of males and females with a change in PC1	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC2	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC3	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC4	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC5	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC6	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC7	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC8	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC9	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Part B: Compare proportion of males and females with a change in PC10	Comparison between proportions of sexes diagnosed with concussion and their corresponding PC levels	12 weeks post-injury
Number of Unanticipated Adverse Device Effects	Frequency of UADEs	Through study completion, up to 1 year

Collaborators and Investigators

• Sponsor: Neurolytixs

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: NLI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No