Blood Biomarker Study to Diagnose Adolescent Sport Concussion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Brain Concussion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Neurolytixs Index

Intervention Type DIAGNOSTIC_TEST

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.

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.

Group Type EXPERIMENTAL

Neurolytixs Index

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes