RecruitingACTRN12623000259640

An observational study exploring outcomes following concussion to optimise recovery

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

Sponsor

Curtin University

Enrollment

200 participants

Start Date

Mar 20, 2024

Study Type

Observational

Conditions

Persistent post-concussion symptoms Concussion

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.

Eligibility

Sex: Both males and femalesMin Age: 14 YearssMax Age: 65 Yearss

Inclusion Criteria6

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

Exclusion Criteria22

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
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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Interventions

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

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.