Traumatic Brain InjuryNCT04070092
The Impact of Traumatic Brain Injury in the Elderly
An observational study of Traumatic Brain Injury, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Jul 2019to 31 Dec 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- ≥ 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.
Who cannot join
- < 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Traumatic Brain Injury in the Elderly: a Prospective Study
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.
Read the detailed description
In order to achieve the goals of the project, a cohort of 50 patients and 50 volunteers is expected, and the following evaluations will be performed:
For the patients group, after signing the informed consent form, a clinical data collection, a serum-based injury biomarkers study, a brain damage assessment, a cognitive and motor assessment, a sleep quality and a quality of life evaluation will be performed.
- 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.
- 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.
- 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.
- 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. 1st evaluation session with the patient: 6 months after the injury, the patient will be called back to UZ Leuven for evaluation.The protocol for this session will be done in 1 or 2 sessions, depending on the preferences of the patient, and will consist of:
- 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 the results will be interpreted with the Icobrain TBI report, provided by Icometrix.
- 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.
- Motor assessment: it will be performed using the Berg Balance Scale (BBS), Timed Up an Go (TUG) test, Timed Up and Go with cognitive dual task (TUGcog) test, Box-and-block test and a cycling test performed with a bicycle simulator created by the IMPAct group (KU Leuven).
- Sleep quality assessment: the sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index, in order to understand how TBI can affect the patients' sleep patterns.
- 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.
All the results will be compared with the results obtained in the control group.
If the patient chooses to have two evaluation sessions, instead of one, the first session will be dedicated to the MRI scan and the second session will be dedicated to the cognitive, motor, sleep quality and quality of life evaluation. Both sessions will be performed within the same week.
For the control group, after signing the informed consent form MRI scans, a cognitive and motor assessment, sleep quality and quality of life evaluation will be performed in this group at the time of recruitment, in one or two sessions, depending on the preference of the volunteer. All the assessments will be performed in University Hospitals Leuven and the results will be compared with the patients group's results.
- 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 volunteer and the results will be interpreted with the Icobrain TBI report, provided by Icometrix, and compared with the results obtained for the patients.
- Cognitive assessment: CANTAB test will be used to study cognitive functions in this group, as it is a validated and reliable computerized neuropsychological battery, consisting of memory, learning, attention, problem solving and executive function test. Moreover, the volunteers level of education will be asked, registered and correlated with the results obtained in our evaluations.
- Motor assessment: it will be performed using the Berg Balance Scale (BBS), Timed Up an Go (TUG) test, Timed Up and Go with cognitive dual task (TUGcog) test, Box-and-block test and a cycling test performed with a bicycle simulator created by the IMPAct group (KU Leuven).
- Sleep quality assessment: the sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index.
- Quality of life evaluation: the quality of life in this group 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.
If the volunteer chooses to have two evaluation sessions, instead of one, the first session will be dedicated to the MRI scan and the second session will be dedicated to the cognitive, motor, sleep quality and quality of life evaluation. Both sessions will be performed within the same week.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Elderly, Cognitive Impairment, Motor impairment, Brain injury, Quality of life, Impact, Health care economic costs
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction, Brain Injuries, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: September 2019-December 2022
Sleep quality assessment
The sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index
Measured: May 2021-December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start29 Jul 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Search for new funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Bart Depreitere, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Bart Depreitere, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070092
- Sponsor's protocol ID
- S62845
- Status last verified
- May 2024
- First submitted
- 23 Aug 2019
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Traumatic Brain Injury in the Elderly: a Prospective Study
- ClinicalTrials.gov ID
- NCT04070092
- Acronym / sponsor ID
- S62845
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Elderly, Cognitive Impairment, Motor impairment, Brain injury, Quality of life, Impact, Health care economic costs
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Search for new funding
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In order to achieve the goals of the project, a cohort of 50 patients and 50 volunteers is expected, and the following evaluations will be performed:
For the patients group, after signing the informed consent form, a clinical data collection, a serum-based injury biomarkers study, a brain damage assessment, a cognitive and motor assessment, a sleep quality and a quality of life evaluation will be performed.
- 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.
- 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.
- 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.
- 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. 1st evaluation session with the patient: 6 months after the injury, the patient will be called back to UZ Leuven for evaluation.The protocol for this session will be done in 1 or 2 sessions, depending on the preferences of the patient, and will consist of:
- 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 the results will be interpreted with the Icobrain TBI report, provided by Icometrix.
- 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.
- Motor assessment: it will be performed using the Berg Balance Scale (BBS), Timed Up an Go (TUG) test, Timed Up and Go with cognitive dual task (TUGcog) test, Box-and-block test and a cycling test performed with a bicycle simulator created by the IMPAct group (KU Leuven).
- Sleep quality assessment: the sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index, in order to understand how TBI can affect the patients' sleep patterns.
- 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.
All the results will be compared with the results obtained in the control group.
If the patient chooses to have two evaluation sessions, instead of one, the first session will be dedicated to the MRI scan and the second session will be dedicated to the cognitive, motor, sleep quality and quality of life evaluation. Both sessions will be performed within the same week.
For the control group, after signing the informed consent form MRI scans, a cognitive and motor assessment, sleep quality and quality of life evaluation will be performed in this group at the time of recruitment, in one or two sessions, depending on the preference of the volunteer. All the assessments will be performed in University Hospitals Leuven and the results will be compared with the patients group's results.
- 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 volunteer and the results will be interpreted with the Icobrain TBI report, provided by Icometrix, and compared with the results obtained for the patients.
- Cognitive assessment: CANTAB test will be used to study cognitive functions in this group, as it is a validated and reliable computerized neuropsychological battery, consisting of memory, learning, attention, problem solving and executive function test. Moreover, the volunteers level of education will be asked, registered and correlated with the results obtained in our evaluations.
- Motor assessment: it will be performed using the Berg Balance Scale (BBS), Timed Up an Go (TUG) test, Timed Up and Go with cognitive dual task (TUGcog) test, Box-and-block test and a cycling test performed with a bicycle simulator created by the IMPAct group (KU Leuven).
- Sleep quality assessment: the sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index.
- Quality of life evaluation: the quality of life in this group 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.
If the volunteer chooses to have two evaluation sessions, instead of one, the first session will be dedicated to the MRI scan and the second session will be dedicated to the cognitive, motor, sleep quality and quality of life evaluation. Both sessions will be performed within the same week.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Sleep quality assessment
Time frame: May 2021-December 2022
The sleep quality in our cohort will be assessed using the Pittsburgh Sleep Quality Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Depreitere, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection (time frame: September 2019-December 2022). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.