Rationale and Objective: Up till now, neuronal correlates of post-stroke epilepsy and the comorbid cognitive dysfunction in patients are largely unknown. Therefore, the aim of this study is to unravel imaging biomarkers of post-stroke epilepsy. We…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- BBB permeability as determined by DCE-MRI to assess the leakiness of the
cerebral vasculature by dynamically measuring the rate of contrast agent
transfer from blood into the interstitial space (leakage rate; units: mL / (min
100 g tissue)). We will compare BBB permeability in PSE patients with non-PSE
patients and healthy controls.
- Perfusion as determined by DSC MRI. With this method we obtain information
about the CBF, the cerebral blood volume (CBV), and mean transit time (MTT). We
will compare these in PSE patients with non-PSE patients and healthy controls.
- Resting state functional MRI: connectivity measures, locally as well as whole
brain network analysis (using graph theoretical measures) as well as DTI
connectivity measures, locally (mean diffusivity/fractional anisotropy) and
anatomical features (measured by standard T2, SWI and FLAIR sequences:
gliosis, iron deposits microbleeds, dilated perivascular spaces, and cortical
and subcortical ischemic lesions).
Secondary outcome
- Stroke and post-stroke epilepsy outcome will be assessed using the NIHSS.
- All patients and healthy controls will undergo cognitive testing:
• To assess level of function Raven's Progressive Matrices is used.
• To assess central processing speed the CVST will be used.
• In addition the highest premorbid educational level will be determined.
Laesional deficits (such as dysphasia) will be tested at inclusion.
Background summary
Post-stroke epilepsy is a major health concern, especially in an ageing
population as in the Netherlands. Stroke ranks number one in the elderly as a
cause for epilepsy, accounting for up to 33% of new cases.1 80% of stroke
patients have a brain infarct, whereas 20% have an intracranial hemorrhage.
Although an intracranial hemorrhage carries a somewhat higher risk for epilepsy
as compared to a brain infarct, brain infarcts are the dominant cause of
post-stroke epilepsy in the general population, because of the higher incidence
of brain infarcts. There are a number risk factors known for the development of
epilepsy after an infarct, including cortical involvement, location and size.
Also blood-brain barrier permeability may play a significant role. Furthermore
post-stroke epilepsy patients are known to have more cognitive problems
compared to stroke patients without epilepsy.
Study objective
Rationale and Objective: Up till now, neuronal correlates of post-stroke
epilepsy and the comorbid cognitive dysfunction in patients are largely
unknown. Therefore, the aim of this study is to unravel imaging biomarkers of
post-stroke epilepsy. We will assess blood brain barrier (BBB) properties,
perfusion properties and brain network formation in patients with and without
post-stroke epilepsy (PSE), and healthy controls.
Hypothesis:
1. Stronger BBB leakage in the peri-infarct region is associated with
post-stroke epilepsy.
2. Decreased perfusion in the peri-infarct region is seen in the post-stroke
epilepsy and stroke patients.
3. More aberrant brain plasticity in the peri-infarct region is associated with
post-stroke epilepsy.
4. BBB permeability and the extent of aberrant brain plasticity relate to the
cognitive decline.
Study design
Study design: This is an observational cross-sectional study. We will use high
field neuroimaging (7T MRI) to determine BBB permeability (using the DCE
technique), perfusion (using the DSC technique) as well as brain remodeling
(using DTI and rs-fMRI techniques). All patients will undergo cognitive testing
using Raven*s Progressive Matrices and the CVST.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients will undergo 7T. MRI imaging including
gadolinium contrast enhancement . 7T imaging is safe, an adverse reaction to
the intravenous contrast agent is a rare complication, which is very well
treatable.
P. Debyelaan 25
Maastricht 6228WX
NL
P. Debyelaan 25
Maastricht 6228WX
NL
Listed location countries
Age
Inclusion criteria
- Patients suffering from stroke (and post-stroke epilepsy), including both brain infarction, cerebral hemorrhage and clinically significant hemorrhagic transformation of stroke (or a primary intracerebral hemorrhage)
- Patients suffering from post-stroke epilepsy after cortical stroke defined as one or more unprovoked epileptic seizures occurring more than one week after the stroke, according to International League Against Epilepsy criteria.
- Patients suffering from cortical stroke, with the onset of acute stroke symptoms more than 4 months prior to inclusion.
- Age > 18 years
Exclusion criteria
-onset of stroke (and epilepsy for post-stroke epilepsy patients) less than 4 months ago
-In case of the PSE group: onset of epilepsy within a week or 2 years after the onset of stroke.
-previous history of epilepsy
-history of another cerebral disorder (neurodegenerative diseases, tumours)
-inability to provide informed consent
- any contraindication for MRI: metallic foreign body, pacemaker, claustrophobia, pregnancy, tattoos, permanent make-up.
- known contrast allergy to gadolinium, insufficient kidney function (eGFR<=30).
- A history of topiramate use as an anti-epileptic drug, because of its known cognitive effects.
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 | NL57690.068.16 |