Glycocalyx assessment in temporal lobe epilepsy
- Conditions
- temporal lobe epilepsy10042258
- Registration Number
- NL-OMON47782
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Epilepsy patients
- adults between 18 and 60 years
- patients diagnosed with pharmacoresistant epilepsy, temporal lobe epilepsy,
focus in non-eloquent area. , Control patients
- adults between 18 and 60 years
- patients undergoing an elective craniotomy for non-eloquent intracranial
tumor resection or neurovascular indications, like aneurysm clipping and
arteriovenous malformation resection, or undergoing a burr hole for tumor
biopsy.
A potential subject who meets any of the following criteria will be excluded
from participation in this study: child (<18y) or elderly (>60y), pregnancy,
diabetes mellitus, familiar (combined) hyperlipidemia, history of stroke or
other cardiovascular diseases, use of cardiovascular medication, silent signs
of cerebral small vessel disease on brain MRI.
Moreover, control patients in which no *normal*, *non-compressed* and/or
non-edematous* cerebral cortex can be assessed during surgery or in whom a
history of seizures is reported, will be excluded.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is cortical glycocalyxthickness.<br /><br>Glycocalyxthickness is expressed in the two dimensions, PBR and Dperf (both<br /><br>continuous variables in expressed micrometers).<br /><br>PBR and Dperf are presented as mean (±standard deviation) if normally<br /><br>distributed, and as median (range) if non-normally distributed. Differences<br /><br>between the two groups will be calculated using t-test or Mann-Whitney U-test.<br /><br>Missing data will be replaced by a mean or median value. p-value <0.05 is<br /><br>considered statistically significant.</p><br>
- Secondary Outcome Measures
Name Time Method