Primary objective is to investigate whether secondary deterioration after acute stroke is associated with CSD, infraslow activity, or epileptiform activity. Secondary objectives are (1) to assess the feasibility of continuous full-band EEG to…
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Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are (1) neurological deterioration during hospital
admission (=primary outcome measure), and (2) incidence of EEG patterns that
indicate cortical spreading depressions, epileptiform activity, infraslow
activity, of disturbed functional connectivity in the contralesional
hemisphere.
Secondary outcome
Secondary outcome measures will be functional outcome defined as the score on
the mRS, the Barthel index, and major depressive disorder 6-8 weeks after
discharge.
Background summary
14-30% of patients with acute stroke deteriorate during hospital admission. The
pathophysiological mechanisms leading to secondary deterioration are often
unknown and therapeutic consequences are lacking. It has been shown that
cortical spreading depressions (CSDs), infra-slow oscillations, and epileptic
activity may have detrimental effects. Remote network changes in the
contra-lesional hemisphere probably play a role in functional recovery and
incidence of major depressive disorder. We will study the incidence of these
phenoma with electroencephalography (EEG) in patients with acute stroke and
relate these to secondary deterioration, functional recovery and major
depressive disorder.
Study objective
Primary objective is to investigate whether secondary deterioration after acute
stroke is associated with CSD, infraslow activity, or epileptiform activity.
Secondary objectives are (1) to assess the feasibility of continuous full-band
EEG to measure CSD, infraslow activity, and epileptiform activity in patients
with acute stroke; (2) to explore (additional) signal analysis techniques for
detecting CSD, relevant infraslow activity patterns, or epileptiform activity;
(3) to generate hypotheses about which patients with acute stroke are at risk
for secondary deterioration; (4) to relate remote network changes in the
contra-lesional hemisphere to fuctional recovery and major depressive disorder.
(5) To estimate the additional value of high density EEG (64 electrodes) for
analyses of brain functional connectivity measures in stroke patients as
compared with healthy controls.
Study design
This is a prospective observational cohort study of 80 adult patients with
acute stroke admitted to the stroke unit of Medisch Spectrum Twente or
Rijnstate Hospital. In addition, a control group of 10 healthy subjects will be
monitored with EEG for 20-30 minutes. to serve as a reference for the high
density EEG measurements.
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Study burden and risks
Participation implies EEG monitoring for 20-30 minutes, and a diagnostic
interview 6-8 weeks after discharge. EEG is routine, everyday investigation.
Serious or major adverse events are not expected and the risk of an increase of
morbidity or mortality is considered negligible. In case of incidental findings
in the control group, these findings are communicated to the healthy subjects,
unless the subjects notified not wanting to be informed about this finding.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
-Age 18 years or older
-Diagnosis of acute stroke
-Possibility to start EEG monitoring within 48 hours from symptom onset
-Admission to the stroke unit
-Neurological deficit with a National Institutes of Health Stroke Scale (NIHSS) score *2
-Degree of disability before stroke on modified Rankin Scale (mRS) score <3 (no symptoms at all, no significant disability, or a slight disability)
Exclusion criteria
- Any progressive brain illness, such as a brain tumor or neurodegenerative disease
-Expectation that the patient will die due to the stroke
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 | NL50284.044.14 |