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

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

Plain Language Summary

Simplified for easier understanding

A concussion — also called a mild traumatic brain injury — is one of the most common injuries seen in emergency departments. While most people recover fully within a few weeks, a significant number go on to experience persistent symptoms like headaches, memory problems, dizziness, and mood changes for months afterward. Identifying who is at risk of a slow or incomplete recovery is very difficult in the early stages. This study is recruiting people who have just been diagnosed with a concussion in a hospital emergency department. In the first few days after injury, participants complete questionnaires, have blood and saliva samples taken, undergo brain MRI scanning, and complete clinical assessments. Over the following year, they are contacted by phone at regular intervals to track how their symptoms and quality of life are changing. By combining early biological markers, brain imaging, and clinical information, researchers hope to build a model that can predict who needs more intensive follow-up care. You may be eligible if you are between 14 and 65 years old, have been diagnosed with a concussion by a doctor within the last 12 hours, and can attend a follow-up assessment within 4 days. People with existing serious neurological conditions, significant psychiatric illness, or who are pregnant would not be eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(3)

Royal Perth Hospital - Perth

QLD,WA,VIC, Australia

The Alfred - Melbourne

QLD,WA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

QLD,WA,VIC, Australia

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