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Glycocalyx assessment in temporal lobe epilepsy

Glycocalyx assessment in temporal lobe epilepsy - Glycocalyx in epilepsy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47782
Enrollment
30
Registered
2015-05-20
Start date
2016-07-14
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

temporal lobe epilepsy

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: child (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.

Design outcomes

Primary

MeasureTime frame
Primary outcome is cortical glycocalyxthickness. Glycocalyxthickness is expressed in the two dimensions, PBR and Dperf (both continuous variables in expressed micrometers). PBR and Dperf are presented as mean (±standard deviation) if normally distributed, and as median (range) if non-normally distributed. Differences between the two groups will be calculated using t-test or Mann-Whitney U-test. Missing data will be replaced by a mean or median value. p-value

Secondary

MeasureTime frame
Sublingual, cortical and hippocampal comparison Sublingual and cortical glycocalyx dimensions in TLE and control patients will be compared between groups using the two-tailed student*s T-test. Also, differences between sublingual, cortical (and hippocampal in TLE patients) intra-individually will be compared using the two-tailed student*s T-test. Epilepsy type and frequency, age of epilepsy onset (years of epilepsy) Epilepsy-specific factors such as type of seizures and seizure frequency of the included TLE patients will be correlated to glycocalyx dimensions. Statistics used: uni- and multivariate regression analysis. Hippocampal sclerosis In TLE patients the differences in glycocalyx dimensions will be compared between patients with hippocampal sclerosis and no hippocampal sclerosis using the two-tailed student*s T-test. In the hippocampal sclerosis group we will try to correlate the glycocalyx dimensions to the degree of hippocampal sclerosis (using Wyler and Blümcke classicification) using uni- and multivariate regression analysis. History of FS or TBI Differences in glycocalyx dimensions will be compared between TLE patients with and without a history FS or TBI using the two-tailed student*s T-test. Viability of microvascular structures in an in-vitro setting Small arteries will be isolated from resected cortical tissue and positioned in an arteriograph. Next, using vasoconstrictive and vasodilatative agents viability will be examined. This will be illustrated in dose-response curves. Examination of the neurovascular unit in an in-vitro setting Small arteries will be isolated from resected cortical tissue and positioned in an arteriograph. If viable, arteries will be exposed to electrical field stimulation for examination of the neurovascular unit. This will be illustrated using a voltage-response curve. Examination of the glycocalyx in an in-vitro setting Small arteries will be isolated from resected cortical tissue and positioned

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)