ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12623000259640

Ethics application status

Approved

Date submitted

8/02/2023

Date registered

10/03/2023

Date last updated

26/01/2025

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

Scientific title

A prospective cohort study to predict poor outcomes following mild traumatic brain injury

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1287-6061

Trial acronym

CREST-II

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,

Health condition

Health condition(s) or problem(s) studied:

Concussion

Persistent post-concussion symptoms

Mild traumatic brain injury

Condition category

Condition code

Neurological

Other neurological disorders

Injuries and Accidents

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

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.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Existence of Persistent Post-concussive Symptoms (PPCS) as determined by overall score on the Rivermead Post-Consussion Questionnaire (RPQ)

Timepoint [1]

2 weeks, 1 month, 3 months, 6 months and 12 months following mTBI

Secondary outcome [1]

Cognitive function assessed using the Cogstate brief battery (computeristed tests) assessing attention, working memory, psychomotor function and visual learning.

Timepoint [1]

Within 4 days of injury

Secondary outcome [2]

Exploratory outcome: MRI abnormality

Timepoint [2]

Within 4 days of injury

Secondary outcome [3]

Quality of life measured with the Quality of Life after Brain Injury - overall scale (QOLIBRI-OS)

Timepoint [3]

2 weeks, 1-, 3-, 6- and 12- months following injury

Secondary outcome [4]

Exploratory outcome: Abnormal biomarkers in blood and saliva samples

Timepoint [4]

Within 12 hours of injury

Secondary outcome [5]

Vestibular-ocular function assessed with the Vestibular-Oculomotor Screening tool (VOMS)

Timepoint [5]

Within 4 days of injury

Secondary outcome [6]

Total score for balance assessed with the Balance Error Scoring System (BESS)

Timepoint [6]

Within 4 days of injury

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

Minimum age

14 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

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

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, outcome (PPCS or no PPCS), nature of injury (single event or sequelae), and symptoms at presentation.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

26/06/2023

Actual

20/03/2024

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD,WA,VIC

Recruitment hospital [1]

Royal Perth Hospital - Perth

Recruitment hospital [2]

The Alfred - Melbourne

Recruitment hospital [3]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

6000 - Perth

Recruitment postcode(s) [2]

3004 - Melbourne

Recruitment postcode(s) [3]

4029 - Herston

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

The Curtin Health Innovation and Research Institute (CHIRI) Building 305, Curtin University, Kent st, Bentley WA 6102

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Perron Institute for Neurological Research and Translation

Address [2]

Sarich Neuroscience Research Institute 8 Verdun st, Nedlands WA 6009

Country [2]

Australia

Primary sponsor type

University

Name

Curtin University

Address

The Curtin Health Innovation and Research Institute (CHIRI)
Building 305 Curtin University
Kent St, Bentley WA 6102

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Human Research Ethics Committee

Ethics committee address [1]

55 Commercial Rd Prahran VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/01/2023

Approval date [1]

21/06/2023

Ethics approval number [1]

267/23

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.

Trial website

https://www.connectivity.org.au/connecting-to-current-research-projects/aus-mtbi-participant-information/

Trial related presentations / publications

nil

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

Contacts

Principal investigator

Name

Prof Lindy Fitzgerald

Address

Curtin University Level 3, Sarich Neuroscience Institute 8 Verdun st, Nedlands WA 6009

Country

Australia

Phone

+61 08 64570514

Fax

[email protected]

Contact person for public queries

Name

Lindy Fitzgerald

Address

Curtin University Level 3, Sarich Neuroscience Institute 8 Verdun st, Nedlands WA 6009

Country

Australia

Phone

+61 08 64570514

Fax

[email protected]

Contact person for scientific queries

Name

Lindy Fitzgerald

Address

Curtin University Level 3, Sarich Neuroscience Institute 8 Verdun st, Nedlands WA 6009

Country

Australia

Phone

+61 08 64570514

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Principal Investigator

Conditions for requesting access:
• -

What individual participant data might be shared?

• Aggregated data will be shared upon request 12 months after the conclusion of the study.

What types of analyses could be done with individual participant data?

• No analysis specified.

When can requests for individual participant data be made (start and end dates)?

From:
Aggregated data will be shared upon request 12 months after the conclusion of the study, with no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access subject to approvals by Principal Investigator, Melinda Fitzgerald ([email protected])

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically