The Impact of Traumatic Brain Injury in the Elderly (NCT04070092) | Clinical Trial Compass
SuspendedNot Applicable
The Impact of Traumatic Brain Injury in the Elderly
Stopped: Search for new funding
Belgium100 participantsStarted 2019-07-29
Plain-language summary
A better understanding of the impact of Traumatic Brain Injury (TBI) in the elderly, in terms of brain damage, cognitive and motor functions, sleep quality and quality of life is necessary due to the increasing incidence and prevalence of TBI in this population and its high economic impact on society. Therefore, this study aims at describing the short-term consequences of TBI by studying injury patterns, injury severity, risk profiles, brain damage, co-morbidities, post-traumatic history, level of dependency, serum-based injury biomarkers, cognitive and motor functions, sleep quality and quality of life 6 months after TBI. All the obtained results will be integrated in a new prognostic tool for the course of the outcomes of TBI in the elderly population.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for patients:
* ≥ 65 years old
* admitted to UZ Leuven between 2019 and 2023 due to TBI
* all injury severities (mild (GCS 13-15), moderate (GCS 9-12) or severe (GCS ≤8))
* having signed the informed consent to participate in the study.
Inclusion Criteria for healthy volunteers:
* ≥ 65 years old
* having signed the informed consent to participate in the study.
Exclusion Criteria for patients:
* \< 65 years old, admitted to UZ Leuven before 2019
* diagnose of neurodegenerative diseases before the TBI
* cognitive and motor disturbances caused by any other pathology
* previous alcohol/drugs abuse
* not having signed the informed consent to participate in the study.
Exclusion criteria for the healthy volunteers will be:
* \< 65 years old
* diagnose of neurodegenerative diseases
* cognitive and motor disturbances caused by any pathology
* previous alcohol/drugs abuse
* not having signed the informed consent to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.