Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000260426
Ethics application status
Approved
Date submitted
20/11/2024
Date registered
9/04/2025
Date last updated
16/05/2025
Date data sharing statement initially provided
9/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining optimal sampling times for concussion blood biomarkers for prediction of recovery
Scientific title
Determining optimal sampling times for mTBI blood biomarkers for prediction of recovery
Secondary ID [1] 313429 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CBS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild traumatic brain injury 335801 0
Condition category
Condition code
Neurological 332379 332379 0 0
Other neurological disorders
Injuries and Accidents 333290 333290 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.

Intervention code [1] 329992 0
Not applicable
Comparator / control treatment
Healthy controls
Control group
Active

Outcomes
Primary outcome [1] 339934 0
Ubiquintin C-terminal hydrolase-L1 (UCHL1)
Timepoint [1] 339934 0
Primary outcome will be serum UCH-L1 levels between 0- and 24- hours post-injury, and at 72 hours, two weeks, three weeks and finally at months three, five and seven post-injury.
Primary outcome [2] 340859 0
Glial Fibrillary Acidic Protein (GFAP)
Timepoint [2] 340859 0
Primary outcome will be serum GFAP levels between 0- and 24- hours post-injury, and at 72 hours, two weeks, three weeks and finally at months three, five and seven post-injury.
Primary outcome [3] 340860 0
Neurofilament light chain (NfL)
Timepoint [3] 340860 0
Primary outcome will be serum NfL levels between 0- and 24- hours post-injury, and at 72 hours, two weeks, three weeks and finally at months three, five and seven post-injury.
Secondary outcome [1] 445287 0
Health Status of Participants
Timepoint [1] 445287 0
Filled out at initial visit between 0- and 24- hours post-injury
Secondary outcome [2] 445289 0
Brain Health Status of Participants
Timepoint [2] 445289 0
These will be filled out at each visit: between 0- and 24-hours post-injury, and at 72 hours, two and three weeks, and at three, five and seven months post-injury.
Secondary outcome [3] 445290 0
Eye Tracking (10 min)
Timepoint [3] 445290 0
This will be done at the clinic visits, between 0- and 24-hours post-injury, and at 72 hours, two and three weeks, and at three, five and seven months post-injury.
Secondary outcome [4] 445618 0
Brain Health Status of Participants
Timepoint [4] 445618 0
These will be filled out at each visit: between 0- and 24- hours post-injury, and at 72 hours, two and three weeks, and at three, five and seven months post-injury.
Secondary outcome [5] 445619 0
Brain Health Status of Participants
Timepoint [5] 445619 0
These will be filled out at each visit: between 0- and 24- hours post-injury, and at 72 hours, two and three weeks, and at three, five and seven months post-injury.

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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


Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Males and females are to be analysed separately. If a meaningful sample size is achieved, transgender participants who have completed at least six months of gender affirming hormonal therapy may be analysed separately. The molecular biomarkers are continuous, temporally sensitive variables. Descriptive statistics
No assumptions about the normality of potential data have been made. Once data has been collected, the Study Team will make an evaluation and perform normality tests to support a conclusion of likely normal or non-normal distribution. These results will influence the choice of tests of statistical significance.
Correlation studies
Biomarker variables, demographic and clinical characteristics will be compared by Chi Square Test where appropriate.
Statistical testing and modelling
Molecular Markers
Longitudinal data will be analysed with linear mixed models with age and body mass index as covariates. Modelling and covariates, other than age, sex and body mass, will be adjusted as appropriate.
Statistical analysis will be performed with R Studio, version 4.2.2 (R Foundation for Statistical Computing).
Eye tracking
Eye tracking analysis will be performed using software developed through Umajin Inc. to complete data manipulation and time-stamp alignment, extraction of gaze metrics and advanced statistical testing. Inter- and intra-individual differences/ standard deviation between each measure (e.g. saccade amplitude, mean velocity, peak velocity, and fixation error) will then be performed.
Following eye tracking event measure detection and analysis, the study team will evaluate the data for normality, optionally conducting normality testing to support a conclusion of normality or nonnormality. A Wilcoxon rank-sum test will conduct paired difference tests. Pearson correlation (r) will be calculated for each pair of measures (e.g. eye tracking measures and symptom scores) using the corr package in R. Significance of correlation will be calculated using the Hmisc package in R and FDR corrected for multiple testing (FDR p-value < 0.05).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2025
Actual
Date of last participant enrolment
Anticipated
20/05/2027
Actual
Date of last data collection
Anticipated
20/12/2027
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 26746 0
New Zealand
State/province [1] 26746 0
Auckland and Wellington

Funding & Sponsors
Funding source category [1] 317862 0
Commercial sector/Industry
Name [1] 317862 0
Abbott
Country [1] 317862 0
United States of America
Funding source category [2] 317863 0
Charities/Societies/Foundations
Name [2] 317863 0
Vision Research Foundation
Country [2] 317863 0
New Zealand
Funding source category [3] 317864 0
Charities/Societies/Foundations
Name [3] 317864 0
Graduate Women North Shore Charitable Trust
Country [3] 317864 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 320196 0
None
Name [1] 320196 0
Address [1] 320196 0
Country [1] 320196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316543 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316543 0
Ethics committee country [1] 316543 0
New Zealand
Date submitted for ethics approval [1] 316543 0
20/11/2024
Approval date [1] 316543 0
14/03/2025
Ethics approval number [1] 316543 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138218 0
Prof Patria Hume
Address 138218 0
Auckland University of Technology, AUT Millennium, 17 Antares Place, Mairangi Bay; Private Bag 92006, Auckland 1142, New Zealand
Country 138218 0
New Zealand
Phone 138218 0
+64 021805591
Fax 138218 0
Email 138218 0
[email protected]
Contact person for public queries
Name 138219 0
Patria Hume
Address 138219 0
Auckland University of Technology, AUT Millennium, 17 Antares Place, Mairangi Bay; Private Bag 92006, Auckland 1142, New Zealand
Country 138219 0
New Zealand
Phone 138219 0
+64 021805591
Fax 138219 0
Email 138219 0
[email protected]
Contact person for scientific queries
Name 138220 0
Patria Hume
Address 138220 0
Auckland University of Technology, AUT Millennium, 17 Antares Place, Mairangi Bay; Private Bag 92006, Auckland 1142, New Zealand
Country 138220 0
New Zealand
Phone 138220 0
+64 021805591
Fax 138220 0
Email 138220 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No individual data will be available for sharing.



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24724Study protocol    1 mTBI blood sample HDEC PROTOCOL 120525 version 2 (1).pdf
24725Other    Participant Information Sheet Study 1 mTBI blood sample HDEC PIS 120525 (1).pdf
24726Informed consent form    WHN Study 1 mTBI blood sample HDEC CONSENT 050525.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.