The research project focuses on identifying early predictors (brain damage, cognition and behavior) for recovery after a SAH. The research also focuses on using advanced neuro-imaging for better mapping of (indicators of) brain damage after a SAH,…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure consists of the score on the Impact on
Participation and Autonomy (IPA) (Cardol, 2005) questionnaire 1 year after SAH.
Secondary outcome
- The score on the IPA 2 years after SAH;
- The score on the mRS 1 and 2 years after SAH;
- Performance on neuropsychological tests (intelligence, memory, attention,
mental speed, language, visuoconstruction skills, executive functions and
social cognition);
- Scores on questionnaires (complaints, fatigue, anxiety/depression, stress,
coping, personality, behavior, quality of life)
- Neuro-imaging outcomes (RS-fMRI, DWI, VBM)
o ASL/VAI: cerebral blood flow (CBF), cerebral blood volume (CBV), vessel size,
oxygen saturation, vessel architecture
o DTI: fractional anisotropy (FA) en apparent diffusion coefficient (ADC)
o SWI/QSM: affected tissue volume en hemosiderosis volume
o Synthetic MRI: quantitative T1, T2, proton density (PD) values.
Background summary
A subarachnoid haemorrhage (SAH) is a serious condition with a high mortality
(30%). After a SAH, diffuse injury occurs, not only due to the initial
bleeding, but also due to complications (vascular spasms, hydrocephalus,
renewed bleeding) and secondary damage. For this reason, there is no clear
relationship between brain damage and outcome after a SAH. Those who survive a
SAH have a high risk of complications and negative long-term effects. Previous
studies have shown that more than 50% of all patients are unable to resume
previous work even in the absence of physical limitations (Al-Khindi,
Macdonald, & Schweizer, 2010; Passier, Visser-Meily, Rinkel, Lindeman, & Post,
2011). In addition, patients experiences problems in carrying out leisure
activities and social contacts after a SAH (Buunk, Groen, Veenstra, & Spikman,
2015).
Cognitive, emotional and behavioral consequences may occur after a SAH. For
example, after a SAH both disorders in basic cognitive functions (memory,
attention, pace and language) and so-called 'higher order' functions (executive
functions, social cognition) are found (Al-Khindi et al., 2010; Buunk et al.
al., 2016; Rinkel & Algra, 2011). Other possible residual symptoms of a SAH are
subjective complaints such as fatigue and anxiety and mood complaints. In
addition, changes in behavior and personality are found regularly (Buchanan,
Elias, & Goplen, 2000; Ogden, Utley, & Mee, 1997; Storey, 1972).
In the existing literature, little is known about the early predictors of
long-term recovery after SAH. In this context, recovery is understood as
functioning at the participation level, with emphasis on both resuming and
maintaining work and social life in the long term. The focus of the current
study is on increasing this knowledge by following 150 SAB patients for two
years. A neuropsychological examination and MRI scan are performed 6 months
after the SAH (standard clinical care). In addition, 6 months, 1 year and 2
years after SAB questionnaires will be sent to map, among other things,
emotional and behavioral changes, fatigue, quality of life and resumption of
work and social activities (in the context of research).
In previous studies, imaging techniques such as Magnetic Resonance Imaging
(MRI), have been used to better understand the outcomes of a SAH and to
ultimately predict them. However, the use of these methods in predicting
outcomes after a SAH remains experimental (de Oliveira Manoel et al., 2014) and
in particular the consequences of white matter lesions are unknown. We believe
there are some promising imaging techniques, which are not or barely used, that
can help in research on the (cognitive) effect of SAH and the predictive value
of long-term outcome. First, Diffusion Tensor Imaging (DTI) can map the
relationship between (damage to) white matter pathways and cognitive and
behavioral complaints. Only few studies used DTI to study brain damage after
SAH (Chaudhary et al., 2015; Sener et al., 2016; Yeo et al., 2012). The
relation between outcome (daily functioning, complaints, cognitive functions)
and DTI has not yet been studied. There are some MRI techniques that have not
yet been used in SAH patients: Arterial Spin Labeling (ASL), Quantitative
Susceptibility Mapping (QSM), Vessel Architectural Imaging (VAI) and Synthetic
MRI. ASL and QSM data can be used to measure respectively the blood
transduction of brain tissue (perfusion) and the quantitative damage of blood
products outside the vessels. In addition, VAI is a new Dynamic Susceptibility
Contrast (DSC) perfusion sequence that can demonstrate microvascular
architecture and oxygen saturation status. Finally, synthetic MRI is a
technique whereby a single scan can create multiple different contrast weighted
snapshots and can quantify myelin and damage. In short, the application of new
techniques can perform important new insights into cognitive impairment and
limited mode after an SAB.
Study objective
The research project focuses on identifying early predictors (brain damage,
cognition and behavior) for recovery after a SAH. The research also focuses on
using advanced neuro-imaging for better mapping of (indicators of) brain damage
after a SAH, which will also be included as predictors. In this context,
recovery is understood as functioning at the participation level, emphasizing
both resuming and maintaining work and social life in the long term.
Study design
This is a longitudinal study in which patients are followed for two years.
Study burden and risks
The neuropsychological assessment, the MRI scan and questionnaires can be
exhausting for patients. Both the neuropsychological assessment and the MRI
scan are part of standard clinical care, but additional sequences will be added
to the MRI scan. Because of the VAI, patients will receive contrast for this
MRI. They will undergo a venipuncture in the elbow. This has very limited risk,
however, in exceptional cases a local bleeding may occur. There is also the
risk of an allergic reaction to the contrast medium used in our study
(Dotarem), although this is extremely rare. Patients will be informed about
adding additional MRI sequences and the total MRI scan will take approximately
one hour. The neuropsychological assessment takes a maximum of three hours,
during which time patients can take a break. 6 months, 1 year and 2 years after
SAB, questionnaires will be sent, which patients can complete at home.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. A SAH patient, the diagnosis being based on clinical features in combination
with CT angiography (CTA) or digital subtraction angiography (DSA).
2. The patient must be able to understand the instructions of the
neuropsychological assessment and be mentally and physically able to undergo
the research activities; this will be assessed in a consultation between the
treating doctor (neurosurgeon) and researcher (neuropsychologist).
3. Sufficient knowledge of the Dutch language.
4. Age 18 or older
Exclusion criteria
A limited physical and/or cognitive condition which makes it impossible for
patients to undergo the neuropsychological assessment and MRI.
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 | NL69873.042.19 |