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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Zubair Ahmed
+44 (0)121 4148854
z.ahmed.1@bham.ac.uk


Study Location:

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Be Part of Research - Trial Details - Traumatic brain injury related changes in military veterans

Traumatic brain injury related changes in military veterans

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Traumatic brain injury


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Traumatic brain injury (TBI) results from a violent blow or jolt to the head and occurs most commonly from motor vehicle collisions, falls and interpersonal violence. Military personnel are at high risk of TBI and in recent conflicts, UK military personnel sustained TBI caused by improvised explosive devices, rocket-propelled grenades and gunshot wounds. Most people affected had mild TBI (mTBI), which has emerged as a signature injury in military personnel (one that defines the consequences of the conflict on the soldiers involved). The symptoms of mTBI include memory problems, confusion and disorientation, problems articulating words, headache, dizziness and problems seeing. The problems often resolve soon after injury, but occasionally can last for a long time after the initial TBI. Worryingly however, 1 in 5 people go on to to develop mental health problems within 12 months after mTBI with 75% experiencing mental health problems within 5 years. This suggests that the initial TBI results in permanent brain damage causing mental health issues. The reasons why mental health problems develop in TBI patients are currently not understood. This study aims to understand the changes that occur after TBI in military veterans and correlate these with blood tests, changes in vision, clinical assessments of mental health and patient-reported outcomes for quality of life that encompass daily living and mood. This approach offers a comprehensive way of capturing data on multiple systems affected by TBI and allows us to monitor patient progression over time and pinpoint the changes that determine long-term outcomes in veterans.
This research will identify blood tests and eye signs that can diagnose and predict outcomes after TBI. This research will benefit the veteran population by helping to diagnose their symptoms early and to be able to put in place management options, including drug interventions that will improve the lives of veterans. In addition, the research will benefit the wider veteran population by demonstrating that targeted research-led solutions can have a positive impact on day-to-day living and may support more engagement with researchers to find solutions to unique problems faced by veterans, once discharged from the military. This research will also be applicable to civilian TBI and hence provide additional benefits.
The aim of this study is to evaluate candidate fluid biomarkers in blood and saliva from veterans who have suffered a TBI and correlate these with visual assessments, standard clinical assessments of mental health and patient-reported outcome measures that assess mental health and quality of life over time. All of the data will be combined to develop a multifaceted algorithm to predict prognosis in veterans and provide pilot data to inform a larger study. The study will also identify biomarkers that can enable rapid decisions as to whether further intervention is required to prevent significant changes to quality of life in veterans with a TBI and inform rehabilitation strategies to increase optimal management opportunities.
The objectives of the study are: (1), to evaluate candidate biomarkers in blood and saliva from veterans and non-veterans with traumatic brain injury and correlate these with visual and mental health assessments and patient-reported outcome measures; (2), to assess mental health status in traumatic brain injured patients and correlate these with changes in patient reported outcomes to assess quality of life over time; (3), to relate these changes after traumatic brain injury to understand how quality of life is affected by injury.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2023 30 Oct 2024

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39160095/ (added 20/08/2024)

The researchers will collect blood on enrolment to the study and then again at 6 and 12 months whilst patient-reported outcomes, involving questionnaires, will be filled in by all patients on enrolment and every 3 months. Only for the blood collection is a visit to the hospital required whilst patient-reported outcomes can be filled in and posted in prepaid envelopes. The acute TBI and veterans groups will also receive in-hospital visual field assessments, clinician-led psychiatric assessment and blood collection on enrolment and at 6 and 12 months.


Participants will be sought to include into three study groups: a control group with no previous history of TBI or head injury; an acute TBI group who are recruited within 14 days after a head injury, and a veteran group who have a diagnosis and head injury. Study participants must be over 18 years old, male or female, must have two eyes, the capacity to consent and a willingness to follow the study protocol and must not be pregnant if female. The control group should not have a prior history of TBI or head injury whilst the acute and veteran TBI groups must have a diagnosis of head injury to be eligible.

You can take part if:



You may not be able to take part if:


Exclusion criteria for all groups:1. Patients under 18 years old2. Patients registered as sight-impaired or severely sight-impaired3. Any known prior pre-existing neuropsychiatric condition: dementia, epilepsy on neuro-epileptic drugs, Parkinson's disease, hereditary neurodegenerative conditions, any known retinal or optic nerve disorder of either eye, pregnancy

Additional exclusion criteria for the control group only:Patients have not suffered a TBI or head injury


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospitals Birmingham
    Mindelsohn Way Edgbaston
    Birmingham
    B15 2TH

The risks of participating in this trial are minimal as they involve simple tests that are routinely performed by trained staff. Although there may be no direct benefit, it is hoped that an early detection of changes in eye structure and visual outcome after head injury may be of benefit to future patients with head injuries, by allowing early access to treatments.


The study is sponsored by University of Birmingham and funded by Office of Veterans Affairs, The Cabinet Office.




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Read full details for Trial ID: ISRCTN13276511

Or CPMS 57179

Last updated 20 August 2024

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