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The Impact of Traumatic Brain Injury in the Elderly

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ClinicalTrials.gov Identifier: NCT04070092
Recruitment Status : Not yet recruiting
First Posted : August 27, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
prof. dr. Bart Depreitere, Universitaire Ziekenhuizen Leuven

Brief Summary:
A better understanding of the impact of Traumatic Brain Injury (TBI) in the elderly, in terms of brain damage, cognitive and motor functions, 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, 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.

Condition or disease
Traumatic Brain Injury

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
TBI group

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.

  • Inclusion criteria will be: ≥ 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)), and having signed the informed consent to participate in the study.
  • Exclusion criteria will be: < 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, and not having signed the informed consent to participate in the study.
Control group

A cohort of healthy volunteers with similar demographic characteristics will be recruited as a control group.

  • Inclusion criteria will be: ≥ 65 years old and having signed the informed consent to participate in the study.
  • Exclusion criteria will be: < 65 years old, diagnose of neurodegenerative diseases, cognitive and motor disturbances caused by any pathology, previous alcohol/drugs abuse, and not having signed the informed consent to participate in the study.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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
Blood samples for biomarkers study


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A cohort of patients ≥65 years old admitted to UZ Leuven between 2019 and 2023 due to TBI (patients group) and a cohort of healthy volunteers with similar demographic characteristics (control group) will be studied.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04070092


Locations
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Belgium
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Rebeca Alejandra Gavrila Laic, MSc    +32 16 32 30 17    rebecaalejandra.gavrilalaic@kuleuven.be   
Principal Investigator: Bart Depreitere, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: prof. dr. Bart Depreitere, clinical professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04070092     History of Changes
Other Study ID Numbers: S62845
First Posted: August 27, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by prof. dr. Bart Depreitere, Universitaire Ziekenhuizen Leuven:
Traumatic Brain Injury
Elderly
Cognitive Impairment
Motor impairment
Brain injury
Quality of life
Impact
Health care economic costs
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System