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Discovery of serum biomarkers for the diagnosis of sport-related concussion in children.

Discovery of serum biomarkers for the diagnosis of sport-related concussion in children.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000022965
Enrollment
200
Registered
2020-01-15
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is to assess whether serum tryptases released from degranulating mast cells alone, or in combination with other neuron-specific candidates, can serve as a reliable and rapid biomarker for sports related concussion in children. We hypothesis that a rapid increase in serum tryptases released from degranulating mast cells in the brain, alone or in combination with selected neuron-specific proteins, is a reliable indicator of concussion in young people. This study aims to determine whether biomarkers released following a concussion is an accurate tool for the diagnosis and management of sports related concussions.

Interventions

2 groups of participants will be observed. Healthy controls and patient's with a diagnosed sports related concussion/minor traumatic brain injury. Diagnosis will be confirmed by medical specialists through a medical history and examination. Further evaluation will use the Sports Concussion Assessment Tool 5 and other cognitive assessment tools. Concussion may be caused either by a direct blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head. Conc

2 groups of participants will be observed. Healthy controls and patient's with a diagnosed sports related concussion/minor traumatic brain injury. Diagnosis will be confirmed by medical specialists through a medical history and examination. Further evaluation will use the Sports Concussion Assessment Tool 5 and other cognitive assessment tools. Concussion may be caused either by a direct blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head. Concussion typically results in the rapid onset of short-lived impairment of neurological function that resolves spontaneously. However, in some cases, signs and symptoms evolve over a number of minutes to hours. Concussion may result in neuropathological changes, but the acute clinical signs and symptoms largely reflect a functional disturbance rather than a structural injury and, as such, it is currently thought that no abnormality is seen on standard structural neuro-imaging studies. Concussion results in a range of clinical signs and symptoms that may or may not involve loss of consciousness. Resolution of the clinical and cognitive features typically follows a sequential course. However, in some cases symptoms may be prolonged. We will observe patients diagnosed with a concussion for a total of 28 days, over which time participants will undergo clinical evaluation, cognitive testing and exercise testing, in addition to measurement of serum biomarkers. Healthy participants will have a single measurement of the biomarkers to determine normative values for non-concussed, age matched participants.

Sponsors

UNSW
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

Males and females between the ages of 10-18 years participating in high-contact (impact) sports (patients) and age and sex matched young people not involved in high-contact (impact) sports (controls).

Exclusion criteria

Potential participants with acute exacerbation of allergic inflammation including but not restricted to asthma, eczema, food allergy or anaphylaxis, individuals with recent head injury (<6 months), existing neurological or non-neurological chronic diseases, recent major surgery or those who suffered multiple injuries in the current incident will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026