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

Not Applicable

Recruiting

• Conditions: Concussion; Persisting Post-concussion Symptoms; Neurological - Other neurological disorders

• Registration Number: ACTRN12619001226190
• Lead Sponsor: Curtin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-05
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

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

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 Post-concussion symptom scale (PCSS)[1 (primary timepoint), 3, 6 and 12-months following the date of the concussion injury]

Secondary Outcome Measures

Name	Time	Method
Indexed score on neuropsychological tests[Within 7 days post-injury];Heart rate threshold on Buffalo Concussion Bike Test[Within 7 days post-injury];Abnormality on MRI[Within 7 days post-injury];Increase in glial fibrillary acidic protein in blood [Within 7 days post-injury];changes in other blood biomarkers as an exploratory outcome, [within 7 days post-injury];changes in networks assessed using qEEG[within 7 days post-injury];Vestibular ocular motor test VOMS[within 7 days post-injury];Changes in saliva biomarkers[within 7 days post-injury]