The primary objective is to study the relationship between DAI lesions on conventional MRI, clinical parameters and prognosis. As secondary objective is the additive value of more advanced MR Imaging in which white matter tracts are analysed (as…
ID
Source
Brief title
Condition
- Injuries NEC
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The clinical outcome measured by the Glasgow Outcome Scale- Extended (GOS-E) at
12 months is the primary outcome in this study.
Secondary outcome
The secondary study parameters are
* Health related Quality of Life (QOLIBRI) at 6 and 12 months
* GOS-E at discharge, 6 and 12 months
* IQCODE as filled out by a relative or other informant of the subject
* CNS Vital Signs at 12 months
* Anxiety and depression measured with HADS score at 12 months
Background summary
Traumatic brain injury (TBI) causes different primary lesions, such as
intracranial hematomas, cortical contusions as well as diffuse axonal injury
(DAI). DAI is typically identified on T2* or SWI MRI scans and frequently
present in severe TBI patients.
The axonal injury results from the stretching and deformation of the brain
tissue caused by acceleration-deceleration forces.
DAI can be graded in 3 categories (1 to 3). Whereas stage 3 is often associated
with a poor outcome, the outcome in stage 1 and stage 2 shows conflicting
results. Furthermore, DAI abnormalities seem to have a predilection for certain
brain locations (cerebral white matter, corpus callosum and rostral brainstem).
These DAI lesions probably cause a disruption in local neural networks but the
long-term effect on cognitive functions is unclear. It is expected that a
higher number of DAI and/or DTI lesions result in more cognitive deficits.
Study objective
The primary objective is to study the relationship between DAI lesions on
conventional MRI, clinical parameters and prognosis.
As secondary objective is the additive value of more advanced MR Imaging in
which white matter tracts are analysed (as measured using diffusion tensor
imaging (DTI)) to predict long term functional outcome and cognitive
dysfunction in patients with DAI.
Study design
This will be a prospective observational study in four level 1 trauma centres
(Tilburg, Groningen, The Hague and Enschede).
Study burden and risks
There is no associated risk for participating patients. The observational
character of this study allows supervising doctors to provide best care. An
MRI-scan is part of standard care in this patient group. The performing of a
DWI with Diffusion tensor Imaging processing is not part of standard care, but
will be performed at the same time as the standard MRI-scan. Therefore there is
no extra risk or burden. This extra MRI sequence will not be performed on
participants in the MCH.
The GOSE at discharge means no extra burden for the patient. The GOSE at 6
months will be conducted by a telephone interview and will take 5 minutes. The
GOSE measured at 6 months will be combined with a standard outpatient clinic
visit or the CNS Vital Signs.
The QOLIBRI is a short questionnaire, which takes 7-10 minutes to complete.
(von Steinbuechel, et al., 2012). This questionnaire can be fulfilled during an
outpatient clinic visit, online via a link sent by e-mail or can be sent by
posting.
The HADS questionnaire consist 14 questions, which takes 5-10 minutes to
complete. This questionnaire can be fulfilled during an outpatient clinic
visit, online via a link sent by e-mail or can be sent by posting.
The CNS Vital Signs (30 minutes) is a computerized set of neuropsychological
tests. The patient will have to perform the CNS Vitals in the hospital. The
IQCODE will be fulfilled by a family member or caretaker (10 minutes).
These measurements altogether have a minimal burden for the patient and his/her
caretaker. The results can have valuable conclusions for the treatment of the
individual patients and subsequently can be used in deciding to consult extra
caretakers, for example a psychologist in case of depressive symptoms or a
rehabilitation physician in case of cognitive dysfunction.
Hilvarenbeeksweg 60
Tilburg 5022GC
NL
Hilvarenbeeksweg 60
Tilburg 5022GC
NL
Listed location countries
Age
Inclusion criteria
1) Glasgow Coma Scale Score of 3-12 after Traumatic Brain Injury, measured at trauma site or the Emergency Department
2) Diffuse Axonal Injury on MRI scan of the brain <5 months after trauma
Exclusion criteria
1) patients with clinical history of dementia or mental retardation prior to trauma,
2) patients with mass lesions > 25cc on initial CT-scan of the brain (Marshall score 5 and
6),
3) earlier hospitalization for Traumatic Brain Injury,
4) addiction to alcohol or drugs,
5) unable to attend for follow-up.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL53724.028.15 |