RECRUITING

Blood Biomarker Study to Diagnose Adolescent Sport Concussion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-01
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05287997

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent/assent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Male or female athletes, aged 13-17 inclusive
  1. 1. Individuals who have suffered a known concussion within the 6 months prior to enrollment
  2. 2. Individuals who suffer from an acute neurological disorder
  3. 3. Known pregnancy

Contacts and Locations

Study Contact

Saoirse Cameron, MA
CONTACT
5198600462
scameron@neurolytixs.com
Michael Robinson, PhD
CONTACT
5196368285
mrobinson@neurolytixs.com

Principal Investigator

Douglas D Fraser, MD/PhD
PRINCIPAL_INVESTIGATOR
Neurolytixs

Study Locations (Sites)

Legacy Center Sports Complex
Brighton, Michigan, 48116
United States

Collaborators and Investigators

Sponsor: Neurolytixs

  • Douglas D Fraser, MD/PhD, PRINCIPAL_INVESTIGATOR, Neurolytixs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01
Study Completion Date2023-12

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

  • Brain Concussion