The Impact of Traumatic Brain Injury in the Elderly

NCT04070092 | Suspended

• 1 other identifier: S62845
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Elderly; Cognitive Impairment; Motor impairment; Brain injury; Quality of life; Impact; Health care economic costs

Outcome Measures

Primary Outcomes (9)

• Data collection

  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.

  September 2019-December 2022

• Serum based injury biomarkers study

  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.

  September 2019-December 2022

• CT imaging

  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.

  September 2019-December 2022

• Economic impact prospective analysis

  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.

  September 2019-December 2022

• MRI

  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.

  September 2019-December 2022

• Cognitive assessment

  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.

  September 2019-December 2022

• Motor assessment

  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.

  September 2019-December 2022

• Quality of life evaluation

  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.

  September 2019-December 2022

• Sleep quality assessment

  The sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index

  May 2021-December 2022

Study Arms (2)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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.
• ≥ 65 years old
• having signed the informed consent to participate in the study.

You may not qualify if:

• \< 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.
• \< 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for biomarkers study

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cognitive Dysfunction; Brain Injuries; Tooth, Impacted

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bart Depreitere, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: July 29, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)