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 range65 Years
SexALL
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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.