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Trial registered on ANZCTR


Registration number
ACTRN12619001226190
Ethics application status
Approved
Date submitted
26/07/2019
Date registered
5/09/2019
Date last updated
5/09/2019
Date data sharing statement initially provided
5/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study of concussion in adults to improve recovery and outcomes
Scientific title
A validation study to predict poor outcomes following mild traumatic brain injury
Secondary ID [1] 298652 0
Nil
Universal Trial Number (UTN)
U1111-1236-4142
Trial acronym
CREST - Concussion REcovery STudy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 313544 0
Persisting Post-concussion Symptoms 313545 0
Condition category
Condition code
Neurological 311978 311978 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Phase I: All participants will complete a 15-minute questionnaire about their concussion injury, which will take place over the phone within 48 hours of their injury. Questions are around the nature of the injury, as well as the person's symptoms, particular comorbidities, medical history, and general health and lifestyle.

Phase II: Following the phone questionnaire, eligible participants will be invited to complete a more comprehensive series of tests, including an exercise tolerance test, functional gait assessment, neuropsychological tests, blood biomarker tests and an MRI scan. This occurs on site at the research centre clinic, and takes 2-3 hours.

All participants are followed up by phone at 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.
Intervention code [1] 314915 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320854 0
Existence of Persistent Post-concussive Symptoms (PPCS) as determined by overall score on the Post-concussion symptom scale (PCSS)
Timepoint [1] 320854 0
1 (primary timepoint), 3, 6 and 12-months following the date of the concussion injury
Secondary outcome [1] 374327 0
Indexed score on neuropsychological tests
Timepoint [1] 374327 0
Within 7 days post-injury
Secondary outcome [2] 374328 0
Heart rate threshold on Buffalo Concussion Bike Test
Timepoint [2] 374328 0
Within 7 days post-injury
Secondary outcome [3] 374329 0
Total score out of 30 on Functional Gait Assessment
Timepoint [3] 374329 0
Within 7 days post-injury
Secondary outcome [4] 374330 0
Abnormality on MRI
Timepoint [4] 374330 0
Within 7 days post-injury
Secondary outcome [5] 374331 0
Increase in glial fibrillary acidic protein in blood
Timepoint [5] 374331 0
Within 7 days post-injury

Eligibility
Key inclusion criteria
i) Clinical diagnosis of concussion made by a medical practitioner
ii) Able to be recruited within 48 hours of head injury with symptoms attributable to that injury
iii) Post-Traumatic Amnesia of less than 24 hours
iv) No significant findings on acute brain CT scan, or CT scan not required
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All participants will complete Phase I. Eligible participants that have completed Phase I will complete Phase II, up to a maximum of 120 participants.

Phase I 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 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 28-day follow up e.g. homeless, alcohol dependence.
x) Head injury deemed to be entirely due to primary seizure.

Phase II Exclusion Criteria:
i) Significant other physical trauma that would interfere with physical and/or biochemical outcome assessments and follow up (eg lower limb injuries that would compromise balance or exercise bike testing, or cause changes in blood biomarkers)
ii) Any pre-existing heart conditions that may compromise ability to complete an exercise tolerance test
iii) Epilepsy or history of seizure
iv) 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



Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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, category of injury (mild, moderate, severe), outcome (PPCS or no PPCS), nature of injury (single event or sequelae), and symptoms at presentation.

This is the first registry of its kind in Western Australia. As such there is no existing data to extrapolate power calculations from. However, based on similar research in other countries, feasible outcomes can be generated from population sizes as low as 37 individuals, through to large longitudinal cohorts of more than 10,000.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14317 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 27319 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 303190 0
University
Name [1] 303190 0
Curtin University
Address [1] 303190 0
The Curtin Health Innovation and Research Institute (CHIRI)
Building 305, Curtin University, Kent Street, Bentley WA 6102
Country [1] 303190 0
Australia
Funding source category [2] 303402 0
Charities/Societies/Foundations
Name [2] 303402 0
Perron Institute for Neurological Research and Translation
Address [2] 303402 0
Sarich Neuroscience Research Institute
8 Verdun St, Nedlands, 6009 WA
Australia
Country [2] 303402 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
The Curtin Health Innovation and Research Institute (CHIRI)
Building 305, Curtin University, Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 303444 0
None
Name [1] 303444 0
Address [1] 303444 0
Country [1] 303444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303754 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 303754 0
Level 2 (Ground Floor)
Kirkman House
Royal Perth Hospital
10 Murray Street, Perth WA 6000
Ethics committee country [1] 303754 0
Australia
Date submitted for ethics approval [1] 303754 0
Approval date [1] 303754 0
05/04/2019
Ethics approval number [1] 303754 0
RGS0000003024
Ethics committee name [2] 303931 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 303931 0
Research Office at Curtin
Kent Street
Bentley
Western Australia
6845
Ethics committee country [2] 303931 0
Australia
Date submitted for ethics approval [2] 303931 0
Approval date [2] 303931 0
17/04/2019
Ethics approval number [2] 303931 0
HRE2019-0209

Summary
Brief summary
This is an observational research study to identify markers that can predict poor outcome following a concussion. Following a concussion injury, information will be collected on the individual's injury and medical history, and they will participate in an exercise tolerance test, MRI scan, neuropsychological test and blood test. We hypothesize that performance on tests at the time of the injury will help predict which individuals will likely have a delayed or complicated recovery. Identifying individuals at risk of a poor recovery will help doctors modify their management of the injury appropriately, and save those likely to recovery normally from unnecessary follow-up visits.
Trial website
www.concussionstudy.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94678 0
Prof Melinda Fitzgerald
Address 94678 0
Level 3
Sarich Neuroscience Research Institute
8 Verdun St, Nedlands, 6009 WA
Australia
Country 94678 0
Australia
Phone 94678 0
+61 08 64570514
Fax 94678 0
Email 94678 0
lindy.fitzgerald@curtin.edu.au
Contact person for public queries
Name 94679 0
Prof Melinda Fitzgerald
Address 94679 0
Level 3
Sarich Neuroscience Research Institute
8 Verdun St, Nedlands, 6009 WA
Australia
Country 94679 0
Australia
Phone 94679 0
+61 08 64570514
Fax 94679 0
Email 94679 0
lindy.fitzgerald@curtin.edu.au
Contact person for scientific queries
Name 94680 0
Prof Melinda Fitzgerald
Address 94680 0
Level 3
Sarich Neuroscience Research Institute
8 Verdun St, Nedlands, 6009 WA
Australia
Country 94680 0
Australia
Phone 94680 0
+61 08 64570514
Fax 94680 0
Email 94680 0
lindy.fitzgerald@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The Human Research Ethics Committee requires that all data is held securely within the research environment of the Principle Investigator. Only aggregate data can be shared.
What supporting documents are/will be available?
No other documents available
Summary results
No Results