Blood Biomarker Study to Diagnose Adolescent Sport Concussion

Brain Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287997
• Other study ID #: NLI01
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Neurolytixs
• Contact: Saoirse Cameron, MA
• Phone: 5198600462
• Email: scameron[@]neurolytixs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hill Academy	Caledon	Ontario
United States	Legacy Center Sports Complex	Brighton	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Neurolytixs

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Number of Unanticipated Adverse Device Effects	Frequency of UADEs	Through study completion, up to 1 year
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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	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