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Trial registered on ANZCTR
Registration number
ACTRN12623000259640
Ethics application status
Approved
Date submitted
8/02/2023
Date registered
10/03/2023
Date last updated
21/05/2024
Date data sharing statement initially provided
10/03/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
An observational study exploring outcomes following concussion to optimise recovery
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Scientific title
A prospective cohort study to predict poor outcomes following mild traumatic brain injury
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Secondary ID [1]
308858
0
Nil known
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Universal Trial Number (UTN)
U1111-1287-6061
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Trial acronym
CREST-II
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Linked study record
UTN: U1111-1236-41420, ACTRN12619001226190
ACTRN12619001226190 is the parent study of the current trial.. The current study is continuing with a revised protocol that has a slightly different recruitment criteria and assesses different outcome measures,
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Health condition
Health condition(s) or problem(s) studied:
Concussion
328826
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Persistent post-concussion symptoms
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Mild traumatic brain injury
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Condition category
Condition code
Neurological
325830
325830
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0
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Other neurological disorders
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Injuries and Accidents
326007
326007
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
People who have experienced a mild traumatic brain injury (mTBI) are recruited within 12 hours of their injury. At the time of recruitment, participants will complete a questionnaire about their mTBI in-person with an experienced researcher. Questions will cover the nature of the injury, as well as the person's symptoms, relevant comorbidities, medical history, and general health and lifestyle factors. A blood and saliva sample will also be taken at the time of recruitment, less than 12 hours following injury.
Within 4 days of their injury, participants will attend further in-person testing that will include vestibular and balance assessments, further symptomology assessment, computer-based cognitive testing and undergo an MRI scan. The in-person testing will take approximately 3 hours.
All participants are followed up by phone at 2 weeks, 1-, 3-, 6- and 12-months following their injury. The follow-up questionnaire is based around self-assessment of symptoms and takes around 10 minutes. The total duration of participation is 1 year post-injury.
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Intervention code [1]
325303
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Existence of Persistent Post-concussive Symptoms (PPCS) as determined by overall score on the Rivermead Post-Consussion Questionnaire (RPQ)
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Assessment method [1]
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Timepoint [1]
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2 weeks, 1 month, 3 months, 6 months and 12 months following mTBI
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Secondary outcome [1]
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Cognitive function assessed using the Cogstate brief battery (computeristed tests) assessing attention, working memory, psychomotor function and visual learning.
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Assessment method [1]
417899
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Timepoint [1]
417899
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Within 4 days of injury
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Secondary outcome [2]
417906
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Exploratory outcome: MRI abnormality
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Assessment method [2]
417906
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Timepoint [2]
417906
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Within 4 days of injury
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Secondary outcome [3]
417907
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Quality of life measured with the Quality of Life after Brain Injury - overall scale (QOLIBRI-OS)
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Assessment method [3]
417907
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Timepoint [3]
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2 weeks, 1-, 3-, 6- and 12- months following injury
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Secondary outcome [4]
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Exploratory outcome: Abnormal biomarkers in blood and saliva samples
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Assessment method [4]
417910
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Timepoint [4]
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Within 12 hours of injury
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Secondary outcome [5]
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Vestibular-ocular function assessed with the Vestibular-Oculomotor Screening tool (VOMS)
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Assessment method [5]
417911
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Timepoint [5]
417911
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Within 4 days of injury
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Secondary outcome [6]
417912
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Total score for balance assessed with the Balance Error Scoring System (BESS)
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Assessment method [6]
417912
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Timepoint [6]
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Within 4 days of injury
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Eligibility
Key inclusion criteria
i) Clinical diagnosis of concussion made by a medical practitioner
ii) Aged 14 – 65 years
iii) Able to be enrolled within 12 hours of head injury with symptoms attributable to that injury
iv) Post-Traumatic Amnesia of less than 24 hours
v) No significant findings on acute brain CT scan, or CT scan not required
vi) Willing and able to attend additional in-person assessment within 4 days of injury
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Minimum age
14
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
i) Glasgow Coma Scale <14 at the time of initial assessment
ii) Significant history of pre-existing conditions that would interfere with outcome assessment and follow-up (eg. Substance abuse/alcohol abuse, homelessness, terminal illness)
iii) Significant debilitating pre-existing diagnosed mental health disorder that would interfere with neuropsychological and possibly blood or saliva biomarker outcome measures or follow up (eg schizophrenia, bipolar disorder)
iv) Significant pre-existing neurological condition which may interfere with ability to complete outcome measures or follow up (eg. Stroke, dementia)
v) Pre-existing cognitive impairment such as intellectual disability which may interfere with ability to undertake neuropsychological examination
vi) Non-English speakers or poor English language skills which may interfere with ability to undertake neuropsychological examination
vii) Pregnant women
viii) Prisoners in custody or people known to be involved in illegal activity
ix) Deemed unlikely to comply with scheduled follow ups (e.g. homeless, alcohol dependence).
x) Head injury deemed to be entirely due to primary seizure.
xi) Significant other physical trauma that would interfere with physical and/or biochemical outcome assessments and follow up (eg lower limb injuries that would impede balance assessment, neck injuries that would restrict head movements, or cause changes in blood or saliva biomarkers)
xii) Epilepsy or history of seizures
xiii) Meets exclusion criteria to undertake MRI, which can be any of the following:
• Has cardiac pacemaker or pacing wire in situ
• Has metal surgical clips or staples of any kind (particularly aneurysm clips) in situ
• Has had lap band surgery
• Has electronic inner ear implants (bionic ears)
• Has metal fragments in your eyes (past or present)
• Has electronic stimulators
• Has implanted pumps
• Has metal pins or rods in bones
• Has an IUCD (intrauterine contraceptive device) fitted
• Has shrapnel, bullets or foreign bodies
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Baseline characteristics will be compared between men and women using Chi-square tests for categorical variables and t-tests for continuous variables. The analyses will be repeated by age, outcome (PPCS or no PPCS), nature of injury (single event or sequelae), and symptoms at presentation.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
26/06/2023
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Actual
20/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
1
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC
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Recruitment hospital [1]
23890
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Royal Perth Hospital - Perth
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Recruitment hospital [2]
23891
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The Alfred - Melbourne
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Recruitment hospital [3]
23892
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
39371
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6000 - Perth
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Recruitment postcode(s) [2]
39372
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3004 - Melbourne
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Recruitment postcode(s) [3]
39373
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Curtin University
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Address [1]
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The Curtin Health Innovation and Research Institute (CHIRI)
Building 305, Curtin University, Kent st, Bentley WA 6102
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Country [1]
313079
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Australia
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Funding source category [2]
313083
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Charities/Societies/Foundations
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Name [2]
313083
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Perron Institute for Neurological Research and Translation
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Address [2]
313083
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Sarich Neuroscience Research Institute
8 Verdun st, Nedlands WA 6009
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Country [2]
313083
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
The Curtin Health Innovation and Research Institute (CHIRI)
Building 305 Curtin University
Kent St, Bentley WA 6102
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
314867
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Address [1]
314867
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Country [1]
314867
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312325
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Alfred Hospital Human Research Ethics Committee
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Ethics committee address [1]
312325
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55 Commercial Rd Prahran VIC 3004
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Ethics committee country [1]
312325
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Australia
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Date submitted for ethics approval [1]
312325
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05/01/2023
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Approval date [1]
312325
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21/06/2023
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Ethics approval number [1]
312325
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267/23
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Summary
Brief summary
This observational study will investigate injury characteristics and clinical assessments to measure post-concussion symptoms at different time points in the first year post injury and use this information to predict people who are more likely to have a poor outcome after concussion.
Participants will be recruited via hospital emergency departments following initial medical practitioner assessment and concussion diagnosis. Once consented into the study, participants will complete a questionnaire about their concussion injury and medical history, in addition to having a blood and saliva sample taken. Other clinical assessments and an MRI scan will also be completed within 4 days of their injury. At 2 weeks, 1-, 3-, 6- and 12- months following injury, participants will be contacted via telephone to complete a follow up questionnaire about their concussion symptoms and quality of life post injury.
Having a better understanding of people who are at risk of developing persistent symptoms following a concussion will enable more targeted and timely clinical care to minimise distress and disability that may be experienced as a result of injury.
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Trial website
https://www.connectivity.org.au/connecting-to-current-research-projects/aus-mtbi-participant-information/
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Trial related presentations / publications
nil
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Public notes
Additional ethics reciprocal approvals will be submitted to:
1) Curtin University HREC
2) University of Western Australia HREC
3) Metro North HREC A - The Royal Brisbane and Women's Hospital
4) Royal Perth Hospital HREC
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Contacts
Principal investigator
Name
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Prof Lindy Fitzgerald
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Address
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Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
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Country
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Australia
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Phone
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+61 08 64570514
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Fax
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Query!
Email
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[email protected]
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Contact person for public queries
Name
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Prof Lindy Fitzgerald
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Address
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Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
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Country
124259
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Australia
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Phone
124259
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+61 08 64570514
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Fax
124259
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Email
124259
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[email protected]
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Contact person for scientific queries
Name
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Prof Lindy Fitzgerald
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Address
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Curtin University
Level 3, Sarich Neuroscience Institute
8 Verdun st, Nedlands WA 6009
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Country
124260
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Australia
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Phone
124260
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+61 08 64570514
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Fax
124260
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Email
124260
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Aggregated data will be shared upon request 12 months after the conclusion of the study.
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When will data be available (start and end dates)?
Aggregated data will be shared upon request 12 months after the conclusion of the study, with no end date.
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Available to whom?
Case-by-case basis at the discretion of Principal Investigator
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Available for what types of analyses?
No analysis specified.
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How or where can data be obtained?
Access subject to approvals by Principal Investigator, Melinda Fitzgerald (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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