In this study we will evaluate if neurocognitive disturbances, vascular steal and structural changes in cerebral tissue surrounding an AVM are present in AVM patients. Further, we will evaluate if these aforementioned alterations are correlated and…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are:
- Cambridge Cognitive Examination (CAMCOG) total score controlled for
mood/neuropsychiatric status (to evaluate global cognitive functioning),
- cerebral blood volume, cerebral blood flow, mean transit time (to evaluate
brain perfusion/vascular steal),
- quantitative MR parameters (e.g. T1 and T2 relaxation times) (to evaluate
structural abnormalities in brain parenchyma)
- correlation between (changes in) neurocognitive functioning, (changes in)
brain perfusion and (changes in) quantitative MR parameters, before and after
endovascular treatment.
- predictive value of pre-operative perfusion and quantitative MR parameters
with regard to treatment effect on neurocognitive funtion in patiens
Secondary outcome
Secundary study parameters are:
- Obliteration rate of the AVM after endovascular treatment.
Background summary
Title:
Quantitative MR evaluation of vascular steal in AVM patients: a comparitive
study on normal subjects and on the longitudinal impact of endovascular
treatment in AVM patients concerning neurocognition.
Background of the study:
In patients with cerebral arteriovenous malformations (AVMs) neurocognitive
dysfunction can occur, which has received little attention so far. The
pathophysiological substrate of neurocognitive dysfunction is not clear, some
have postulated that a high flow volume shunted through an AVM fistula may
induce a decrease in cerebral perfusion pressure in surrounding brain tissue,
the so called 'vascular steal' phenomena, resulting in symptomatic cerebral
ischemia with development of neurocognitive deficits. Evaluation of these -
perhaps reversible - structural changes in cerebral tissue surrounding an AVM
can be performed by quantitative and hemodynamic MR imaging.
Study objective
In this study we will evaluate if neurocognitive disturbances, vascular steal
and structural changes in cerebral tissue surrounding an AVM are present in AVM
patients. Further, we will evaluate if these aforementioned alterations are
correlated and subject to change after endovascular treatment. Finally, the
results of this study may indicate that neurocognitive dysfunction may be used
to plan treatment in AVM patients, in addition to the occurence of hemorrhage,
headaches and epilepsy.
Study design
20 AVM patients and 20 control subjects will be included in this pilot study.
Patients who are considered eligible for endovascular treatment will be asked
to participate in this study. Control subjects will be matched to patients
according to age and years of education. Patients and control subjects will
undergo a neuropsychological test battery (duration appr. 3 hours) and will be
scanned for appr. 45 minutes (total MR investigation time 60 minutes). In
patients, neuropsychological testing and MR examination will be repeated 3
months after endovascular treatment. In control subjects, neuropsychological
testing will be repeated to evaluate possible learning effects. The MR
investigation consists of qualitative MR sequences, MR perfusion and
quantitative MR measurements. A total of appr 10 sequences will be performed.
No contrast agent will be administered in control subjects. Patients and
control subjects will receive ear-protection and head-phones for communication
purposes.
Study burden and risks
No side effects of MRI have been proven and MRI is generally assumed to be
completely safe. MRI is the standard investigation in the diagnostic work-up of
AVM patients before endovascular treatment and is standardly being used to
evaluate the effect of endovascular treatment. For the purpose of this study
protocol, MR perfusion and quantitative MR measurements will be added to these
standard sequences, these measurements will take appr. 20 - 25 minutes. The
duration of these extra MR investigations is relatively short. Duration of the
neuropsychological test battery will take appr. 3 hours.
No contrast agent will be administered in control subjects. The MRI examination
in control subjects is non-invasive and the risk to the control subject is
negligible. All procedures have been tested by the researchers involved and
during the examination experienced MR personnel will operate the scanner.
Control subjects will be screened for claustrophobia. The control subject will
be protected against scanner noise. The control subject can withdraw from this
study at any time during the study.
albinusdreef 2
2333 ZA Leiden
NL
albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
AVM patients with age between 18 and 55 years, considered eligible for endovascular treatment, with cerebral AVMs confined to a single hemisphere (the non-affected hemisphere will be used to assess within-patient control values of hemodynamic and quantitative MR parameters). Informed consent will be obtained from all patients.
Control subjects will be matched to patients according to age and intelligence level.
Inclusion criteria for control subjects:
1. healthy male or female subject with age between 18 and 55 years.
2. voluntary participation
3. having given their written informed consent
4. willing to accept use of all anonymized data, including publication, and the confidential use and storage of all data
Exclusion criteria
Patients will be excluded from the investigation if they 1. manifest dural or multiple AVMs; 2. present with intracerebral haematomas, since the presence of intracerebral hematoma may interfere with preoperative neuropsychological testing. Further, resorption of the haematoma probably affects neurocognitive function (and distinction of this effect from treatment effect will pose problems, if possible at all). 3. suffer from any other central nervous system anomaly; 4. have a medical history of chronic drug or alcohol abuse.
Exclusion criteria for control subjects:
1. having a current brain or vascular disease
2. claustrophobia
3. having metal implants or metal objects on the body which cannot be removed
4. mental of physical status that is incompatible with the proper conduct of the study
5. being under medication that may affect neurocognitive function
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 | NL22995.058.08 |