Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04070092 |
| Other study ID # |
S62845 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 29, 2019 |
| Est. completion date |
December 31, 2027 |
Study information
| Verified date |
May 2024 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
