Blood Biomarker Study to Diagnose Adolescent Sport Concussion

NCT05287997 | Unknown

• 1 other identifier: NLI01
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

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.

Conditions

Brain Concussion

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Part B: Determine whether repeated plasma PC measurements over time correlate with injury symptom resolution or clinical recovery

  12 weeks post-injury

Other Outcomes (11)

• Part B: Compare proportion of males and females with a change in PC1

  12 weeks post-injury

• Part B: Compare proportion of males and females with a change in PC2

  12 weeks post-injury

• Part B: Compare proportion of males and females with a change in PC3

  12 weeks post-injury

Study Arms (2)

Baseline

OTHER

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

Concussion

EXPERIMENTAL

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

Interventions

Neurolytixs Index 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.

Baseline; Concussion

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Individuals who have suffered a known concussion within the 6 months prior to enrollment
• Individuals who suffer from an acute neurological disorder
• Known pregnancy

Sponsors & Collaborators

• Neurolytixs: lead

Study Sites (2)

Legacy Center Sports Complex

Brighton, Michigan, 48116, United States

RECRUITING

The Hill Academy

Caledon, Ontario, L7K 1S7, Canada

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Douglas D Fraser, MD/PhD

  Neurolytixs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saoirse Cameron, MA

CONTACT

5198600462; scameron@neurolytixs.com

Michael Robinson, PhD

CONTACT

5196368285; mrobinson@neurolytixs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 18, 2022
• Study Start: June 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

US (1); CA (1)