The Impact of Traumatic Brain Injury in the Elderly
|ClinicalTrials.gov Identifier: NCT04070092|
Recruitment Status : Not yet recruiting
First Posted : August 27, 2019
Last Update Posted : August 29, 2019
|Condition or disease|
|Traumatic Brain Injury|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||The Impact of Traumatic Brain Injury in the Elderly: a Prospective Study|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||January 2, 2023|
A cohort of patients admitted to UZ Leuven from 2019 to 2023 due to Traumatic Brain Injury and fulfilling our inclusion and exclusion criteria will be recruited.
A cohort of healthy volunteers with similar demographic characteristics will be recruited as a control group.
- Data collection [ Time Frame: September 2019-December 2022 ]Injury patterns, injury severity, co-morbidities and post-traumatic history will be prospectively registered in our cohort of patients in order to study which types of accidents are risky to result in poor outcome. This will be done through the data collection in medical records of the patients. Advanced statistical methods, such as Gaussian models, will be applied in order to find relations between input and outcome to the best extent possible. In addition, injury mechanisms will be categorized into classes with more or less similar magnitudes of force and acceleration inputs.
- Serum based injury biomarkers study [ Time Frame: September 2019-December 2022 ]Blood samples from our cohort, taken by UZ Leuven nurses in the context of routine-clinical practice will be studied by the Laboratory for Molecular Neurobiomarker Research in UZ Leuven, through Enzyme-Linked Immunosorbent Assay (ELISA). No data will be available for the control group. The results will be compared to results previously obtained in the Laboratory for Molecular Neurobiomarker Research from healthy patients with similar demographic characteristics.
- CT imaging [ Time Frame: September 2019-December 2022 ]CT images performed in the context of routine clinical practice at admission and follow up will be obtained from the hospital's database. The scans will be carefully studied, using automated reports created by Icometrix and the Marshall Head Injury Scale, in order to quantify brain damage. No data will be available for the control group, so results will not be compared between both groups. These findings will be related with the results obtained in the serum-based injury biomarkers study and cognitive and motor assessments.
- Economic impact prospective analysis [ Time Frame: September 2019-December 2022 ]Hospital costs for the clinical management in our cohort will be extracted from the financial database of UZ Leuven, in order to know what is the economic impact that TBI in the elderly has on society.
- MRI [ Time Frame: September 2019-December 2022 ]High-resolution T1 and T2 weighted imaging sequences will be used to study volumetric and morphological changes in the brain. Moreover, Diffusion Tractography Imaging (DTI) will be used to study changes in white matter. Susceptibility Weighted Imaging (SWI) sequences will also be included in order to study axonal injuries and microbleeds. One MRI scan will be obtained from each patient and healthy volunteer.
- Cognitive assessment [ Time Frame: September 2019-December 2022 ]The CANTAB test will be used to study cognitive functions after TBI, as it is a validated and reliable computerized neuropsychological battery, consisting of memory, learning, attention, problem solving and executive function test. Moreover, the patients' level of education will be asked, registered and correlated with the results obtained in our evaluations.
- Motor assessment [ Time Frame: September 2019-December 2022 ]The following motor assessment tests will be used: Berg Balance Scale (BBS), Timed Up an Go (TUG),Timed Up and Go with cognitive dual task (TUGcog), Box-and-block, and a Cycling test with a bicycle simulator created by the IMPAct group (KU Leuven), which evaluate cycling skills.
- Quality of life evaluation [ Time Frame: September 2019-December 2022 ]The quality of life in our cohort will be assessed with the Quality of Life after Brain Injury (QOLIBRI) tool, in the same session as cognitive and motor outcomes, in order to understand how the quality of life is affected in the elderly population after TBI.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070092
|UZ Leuven||Not yet recruiting|
|Leuven, Belgium, 3000|
|Contact: Rebeca Alejandra Gavrila Laic, MSc +32 16 32 30 17 email@example.com|
|Principal Investigator: Bart Depreitere, PhD|