This study aims to identify potential imaging biomarkers for early identification of patients at risk for PSE, and to elucidate the relationship between BBB permeability and other pathophysiological properties in PSE patients in acute phase and…
ID
Source
Brief title
Condition
- Other condition
- Central nervous system vascular disorders
Synonym
Health condition
Epilepsie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To identify potential imaging biomarkers for early identification of patients
at risk for PSE, by investigating blood-brain barrier leakage in acute phase
and during first stage of rehabilitation.
To elucidate the relationship between blood-brain barrier permeability and
other microstructural (connectivity, integrity) and microvascular properties
(perfusion, diffusivity, blood flow, blood volume) of the brain in PSE
patients. Data acquisition at two time points makes it possible to monitor the
pathophysiological changes between the primary effects and early recovery.
Secondary outcome
To determine the relation between blood-brain barrier integrity and alterations
in structural and functional network formation in the brain. Serial MRI
measurements allow for the evaluation of spontaneous network reorganization
after tissue damage.
Background summary
Post-stroke epilepsy (PSE) is a major complication after stroke, which remains
difficult to predict. Management of PSE can be challenging, as underlying
mechanisms and optimal treatment are undetermined. Blood-brain barrier (BBB)
dysfunction has been associated with the development of PSE, though the exact
course and consequence of increased BBB permeability in epileptogenesis are
unclear. Using new MRI techniques BBB permeability, as well as other
microstructural and microvascular properties of the brain tissue, can be
assessed non-invasively in patients with and without PSE.
Study objective
This study aims to identify potential imaging biomarkers for early
identification of patients at risk for PSE, and to elucidate the relationship
between BBB permeability and other pathophysiological properties in PSE
patients in acute phase and during first stage of rehabilitation.
Study design
To characterize the spatiotemporal dynamics and effects of BBB permeability in
relation to the development of PSE in stroke patients, 3T MRI will be performed
shortly after stroke (within ±6 days) and after 6 weeks. A standardized
neurological evaluation will be performed, taking into account neurological
characteristics (National Institutes of Health Stroke Scale) and the functional
status (modified Rankin scale). The patients will be followed-up every three
months for one year in total, with special attention being paid to development
of epilepsy and the patients functional status.
Study burden and risks
Patients will undergo two MRI scans of approximately 60 minutes including
gadolinium-based contrast administration. Risks concerning contrast agent
administration will be negligible, as patients with an impaired renal function
(eGFR<30mL/min) are excluded from the study. Patients will not benefit directly
from participation in this study. However, to learn more about the development
of post-stroke epilepsy, and to improve the treatment of (possible) PSE
patients, it is necessary to examine stroke patients who are at high risk for
developing epilepsy. All included patients will have large stroke lesions, with
mostly a large deficit in physical but also in cognitive functioning. The
patients often will have very specific deficits, like aphasia or anosognosia
(the inability to recognize your own illness/deficit). In case the patient is
legally incompetent, due to their injuries as a result of stroke, a legal
representative will be involved in the study.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
A SeLECT score 0-9 or a CAVE score 0-4
Age of >= 18 years
Exclusion criteria
Contra-indications for a gadolinium based contrast agent (known allergy or
insufficient kidney function determined by an eGFR <= 30 mL/min)
Contra-indications for MRI scanning (e.g. metal implants, cardiac pacemaker,
claustrophobia, pregnancy)
Previous history of epileptic seizures or other cerebral disorders (e.g.
neurodegenerative diseases or head/brain tumors)
Re-infarction during follow-up
Potential epileptogenic co-morbidities (e.g. alcohol or drugs abuse, cerebral
venous thrombosis, history of brain surgery)
Absence of written informed consent (by a legal representative)
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 | NL74935.068.20 |
| Other | NL8976 |