An observational study exploring outcomes following concussion to optimise recovery
- Conditions
- ConcussionPersistent post-concussion symptomsMild traumatic brain injuryNeurological - Other neurological disordersInjuries and Accidents - Other injuries and accidents
- Registration Number
- ACTRN12623000259640
- Lead Sponsor
- Curtin University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Existence of Persistent Post-concussive Symptoms (PPCS) as determined by overall score on the Rivermead Post-Consussion Questionnaire (RPQ)[ 2 weeks, 1 month, 3 months, 6 months and 12 months following mTBI]
- Secondary Outcome Measures
Name Time Method Cognitive function assessed using the Cogstate brief battery (computeristed tests) assessing attention, working memory, psychomotor function and visual learning. [ Within 4 days of injury];Exploratory outcome: MRI abnormality [ Within 4 days of injury];Quality of life measured with the Quality of Life after Brain Injury - overall scale (QOLIBRI-OS)[ 2 weeks, 1-, 3-, 6- and 12- months following injury];Exploratory outcome: Abnormal biomarkers in blood and saliva samples[ Within 12 hours of injury];Vestibular-ocular function assessed with the Vestibular-Oculomotor Screening tool (VOMS)[ Within 4 days of injury];Total score for balance assessed with the Balance Error Scoring System (BESS)[ Within 4 days of injury]