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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05287997
Other study ID # NLI01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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