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An observational study of concussion in adults to improve recovery and outcomes

A validation study to predict poor outcomes following mild traumatic brain injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001226190
Acronym
CREST - Concussion REcovery STudy
Enrollment
238
Registered
2019-09-05
Start date
2019-08-05
Completion date
2022-12-21
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

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.

Interventions

Phase I: All participants will complete a 30-minute questionnaire about their concussion injury, which will take place over the phone within 7 days 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, neuro

Phase I: All participants will complete a 30-minute questionnaire about their concussion injury, which will take place over the phone within 7 days 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, neuropsychological tests, blood and saliva biomarker tests, quantitative electoencephalography (qEEG) 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.

Sponsors

Curtin University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

i) Clinical diagnosis of concussion made by a medical practitioner ii) Able to be recruited within 7 days 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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 27, 2026