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Determining optimal sampling times for concussion blood biomarkers for prediction of recovery

Determining optimal sampling times for mTBI blood biomarkers for prediction of recovery

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000260426
Acronym
CBS
Enrollment
1000
Registered
2025-04-09
Start date
2025-05-19
Completion date
2027-05-20
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

The study hopes to improve how we detect and manage mild traumatic brain injuries (mTBI) using blood tests and other simple methods, while also understanding how recovery might differ between men and women. This study aims to see if certain substances in the blood (e.g., GFAP and UCH-L1) can help detect and predict recovery from mTBI. We aim to offer insights to improve diagnosis, treatment, and recovery plans for mTBI patients and to address gaps in current knowledge, such as differences in recovery between males and females.

Interventions

mTBI is defined as: Diagnosed with a mild traumatic brain injury (mTBI) by a licensed physician. Healthy is defined as: Healthy controls are defined as males and females of any ethnicity that are 16 years of age or above, representing a heterogenous sample of the normal population. Healthy control participants must be neurologically healthy with no diagnosed or self-reported neurodegenerative conditions or diseases, including, but not limited to; dementia (Vascular, Lewy body, or Frontotemporal

mTBI is defined as: Diagnosed with a mild traumatic brain injury (mTBI) by a licensed physician. Healthy is defined as: Healthy controls are defined as males and females of any ethnicity that are 16 years of age or above, representing a heterogenous sample of the normal population. Healthy control participants must be neurologically healthy with no diagnosed or self-reported neurodegenerative conditions or diseases, including, but not limited to; dementia (Vascular, Lewy body, or Frontotemporal dementia or Alzheimer's disease), Parkinson's, Huntington's, Motor neurone disease and mild cognitive impairment, and no history of acute neurological events or structural brain abnormalities including TBI, stroke, seizure, epilepsy, chronic headache, and brain tumour and no unstable severe medical conditions, for example; cancer, severe coagulopathy, terminal illness, end-stage organ failure, acute kidney dysfunction, chronic kidney dysfunction or renal failure. Healthy controls must not have experienced a mild TBI (mTBI) within 12 months and not be experiencing persistent symptoms from previous mTBI at the time of data collection. Participants must reside in New Zealand and be willing and able to provide informed consent and blood samples for this study. What is involved for patients in this study: Participants involved in this study are required to provide: 1) blood samples; 2) fill out a medical history questionnaire; 3) height and weight recorded; 4) fill out a survey about head injuries; 5) complete a non-invasive eye tracking test. For those with a mTBI, these measures will be repeated over the course of seven months (up to seven clinic visits) to track recovery. List of assessments and the anticipated time required to complete each assessment: In total 60 minutes will be needed for the assessments for participants. For the healthy control group there will be one 60-minute visit required. For the mTBI group there will be seven visits 60-minute visits. These visits will occur at the same timepoints outlined in the primary outcomes, all post-injury. These timepoints are post-injury between 0- and 24-hours post-injury, at 72 hours, then at two and three weeks and then at three, five and seven months. 1) Blood samples (10 min): collected from participants will take 10 minutes. 2) Medical history General Health Questionnaire (GHQ) (10 min): filled in by participants will take 10 minutes. This will include questions about the participants previous menstrual cycle if applicable. As well as current medications and any medical diagnoses. 3) Height and weight (5 min): recorded from self-report or actual measurements where possible (time constraints a limiting factor) will take 5 minutes. 4) Brain health surveys (20 min): Surveys for head injuries filled in by participants will take 20 minutes. mTBI history questionnaire; Brain Injury Screening Tool-10; sports or non-sports related concussion; number of days and number of sessions to recover from mTBI; Perceived Recovery Scale; Glasgow Outcome Scale Extended. 5) Eye tracking (10 min): non-invasive eye tracking test and questionnaire relating to eye health completed by participants will take 10 minutes. For the mTBI group, the overall duration of observation will be up to seven months. For the healthy control group, the overall duration of observation will be one in-clinic visit totalling approximately one hour.

Sponsors

Auckland University of Technology
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for both groups 1. Age: Participants above the age of 16 years. 2. Ethnicity: Any 3. Reside in Auckland or Wellington 4. Participants must be willing to attend data collection sessions and provide blood samples. Inclusion criteria specific to mTBI group 5. For the mTBI group: diagnosed mTBI by a health care professional.

Exclusion criteria

1. Individuals unable to provide infored consent due to cognitive impairment or language barriers 2. Individuals who are unwilling to provide a blood sample 3. Individuals with a history of acute neurological events or structural brain abnormalities including, but not limited to, severe TBI, seizure, epilepsy, stroke, chronic headache, and brain tumour 4. Individuals with a history of neurodegerative disorders including, but not limited to, dementia (Alzheimer’s disease, vascular, Lewy body, frontotemporal dementia), Parkinson’s disease, Huntington’s disease, and motor neurone disease 5. Individuals with unstable, severe medical conditions, including, but not limited to, cancer, severe coagulopathy, terminal illness, end-stage organ failure, acute kidney dyfunction, chronic kidney dysfunction or renal failure. 6. For the healthy control group: an mTBI event within the last 12 months, or lingering symptoms from a previous mTBI at the time of data collection

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026