The objectives of this study are to identify new prognostic factors for recovery after moderate/severe TBI and based on these factors to develop a grading scale for the post-traumatic disturbances of various cognitive and behavioural functions, in…
ID
Source
Brief title
Condition
- Injuries NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
From the functional and structural connectivity networks the following network
parameters will be assessed:
- Centrality of the removed nodes (regions). Centrality of a node measures how
many of the shortest paths between all over node pairs in the network pass
through it.
- Number of connections between the lesion site and the rest of the brain, that
were lost.
- Local and nodal efficiency in the remaining network as the measure of its
robustness.
The global clinical outcome of TBI patients will be evaluated using:
- extended Glasgow Outcome Scale (GOSE)
- functional independence measurement (FIM) score
- neurological examination.
A battery of neuropsychological tests will be performed to assess the outcome
in:
- memory and executive function
- attention
- intellectual function
- speech/language.
Secondary outcome
The association between genetic polymorphisms and outcome.
Background summary
Traumatic brain injury (TBI) is a major cause of death and disability in many
countries. The age range of peak TBI incidence is 15 to 24 years, therefore
survivors may have relatively long life spans to cope with their impairments.
Current imaging techniques for TBI diagnosis (CT and MRI) are able to identify
structural lesions, however there is no direct correspondence between
structural abnormalities and post-traumatic dysfunction or complaints. We
suggest that poor outcome after moderate/severe TBI is associated with
compromised brain network function rather than structural lesions per se. In
this project we will examine the structural and functional connectivity between
various brain regions in TBI patients. This connectivity will be further used
to characterize the brain networks. By comparing the brain networks between TBI
patients with good and poor outcome we will relate particular chronic symptoms
to damage of particular brain network(s). Specifically the location and degree
of damage of the affected networks will be considered as a potential prognostic
factor for recovery of a particular brain function. In addition, possible
mediating effects of genetic polymorphisms will be explored.
Study objective
The objectives of this study are to identify new prognostic factors for
recovery after moderate/severe TBI and based on these factors to develop a
grading scale for the post-traumatic disturbances of various cognitive and
behavioural functions, in particular memory, executive function, and attention.
Study design
A cross-sectional observational study
Study burden and risks
The study only includes non-invasive procedures and risk for the subjects is
minimal. We will ask the consent for one venapuncture. We expect two visits
with a maximal total duration of 4 hours per participant.
Kapittelweg 29
6500 HB Nijmegen
NL
Kapittelweg 29
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years and <= 65 years
- Gender: male and female
- Patients who were diagnosed a moderate or severe TBI > 1 year ago (only applicable to patients)
- Physical and cognitive abilities to undertake neuropsychological testing
- Willingness and ability to give written informed consent and willingness and ability to understand the nature and content, to participate and to comply with the study requirements
Exclusion criteria
- History of severe neurological or somatic disease
- Psychiatric diagnosis (current and past)
- Neurosurgical operations in past
- Chronic alcohol or drug abuse
- Everyday smoking
- Current use of any psychotropic drug
- Penetrating injury to the skull
- Pregnancy
- Metal objects in or around the body (braces, pacemaker, metal fragments, hearing devices)
- Claustrophobia
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 | NL34095.091.10 |