|- candidate number||23383|
|- NTR Number||NTR5568|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-nov-2015|
|- Secondary IDs||NL51594.068.14 |
|- Public Title||Glycocalyx in epilepsy.|
|- Scientific Title||Glycocalyx assessment in temporal lobe epilepsy |
|- hypothesis||Epilepsy is associated with thinner glycocalyx in cerebral microcirculation, but not with systemic microvascular differences (sublingually).|
|- Healt Condition(s) or Problem(s) studied||Temporal lobe, Epilepsy, Glycocalyx|
|- Inclusion criteria||Epilepsy patients|
- adults between 18 and 60 years
- patient diagnosed with pharmacoresistant epilepsy, temporal lobe epilepsy, focus in non-eloquent area.
- adults between 18 and 60 years
- patient diagnosed with cerebral oncological pathology that requires resective brain surgery.
|- Exclusion criteria||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. Control patients in whom a history of seizures is reported.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||11-nov-2015|
|- planned closingdate||10-nov-2019|
|- Target number of participants||30|
|- Interventions||Measurement of sublingual and cerebral (cortical and hippocampal) glycocalyx in temporal lobe epilepsy patients and patients with intracranial tumor. Measurement is performed using a SDF camera. |
|- Primary outcome||To establish glycocalyx properties of temporal lobe epilepsy (TLE) patients. |
|- Secondary outcome||- To establish differences in glycocalyx properties of glycocalyx between TLE patients and controls.|
- To establish the correlation between sublingual glycocalyx measurements and cortical glycocalyx measurements in TLE patients and controls.
- To establish differences in glycocalyx properties between TLE patients with hippocampal sclerosis and those without hippocampal sclerosis.
- To establish differences in glycocalyx between TLE patients with a history of febrile seizures and/or traumatic brain injury and those without a history of febrile seizures and/or traumatic brain injury.
- To establish the correlation of glycocalyx properties in TLE patients to epilepsy-specific factors such as type of seizures and seizure frequency.
- To establish the effect of anesthesia on sublingual glycocalyx measurements in all patients.
- To establish the examination of viability of small cortical arteries in an in-vitro setting using an arteriography.
- To establish the examination of the neurovascular unit of small cortical arteries in an in-vitro setting using an arteriograph and electrical field stimulation.
- To establish the examination of the glycocalyx of small cortical arteries in an in-vitro setting using an arteriograph and 2-photon microscopy and to correlate this to the in-vivo results.
|- Timepoints||Interim analysis yearly and/or after 5 included candidates in both arms. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||M.D. Roel Haeren|
|- CONTACT for SCIENTIFIC QUERIES||M.D. Roel Haeren|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|Fund = Initiator = Sponsor|
|- Publications||Will follow|
|- Brief summary||Rationale: |
Pathophysiology of temporal lobe epilepsy (TLE) has not been elucidated yet. Endothelial dysfunction may play a role. The inner part of the endothelium is lined by glycocalyx. It is the first barrier between vessel lumen and the brain, and is affected in cerebrovascular disease. We hypothesize that in epilepsy patients, the glycocalyx is affected as well.
Main objective: to explore cerebral glycocalyx characteristics in epilepsy patients. Other objectives: to correlate sublingual glycocalyx characteristics to directly measured cerebral glycocalyx characteristics; to establish the effect of anaesthetics on glycocalyx characteristics, to correlate glycocalyx characteristics to hippocampal sclerosis, seizure severity, and history of febrile seizures (FS) or traumatic brain injury (TBI).
Observational case-control study.
Adult TLE-patients suffering from medically refractory seizures who are candidates for resective brain surgery, and adult controls that are undergoing resective brain surgery for oncological indications.
Intervention (if applicable):
Sublingual and cerebral glycocalyx measurements. On admission to the hospital one day prior to surgery the first sublingual glycocalyx measurements will be performed. This sublingual measurement is repeated in the operating theatre after induction of anaesthesia, and immediately prior to resection of the temporal lobe. Cerebral glycocalyx measurements are performed twice: once cortically prior to temporal corticectomy, and once hippocampally prior to hippocampectomy Thus, glycocalyx thickness is measured five times in all patients. Hippocampus glycocalyx will not be measured in the control patients.
Main study parameters/endpoints:
Successful measurement of glycocalyx, expressed in
perfused boundary region (PBR, in ým) and Dperf (in ým), in epilepsy patients and controls.
|- Main changes (audit trail)|
|- RECORD||11-nov-2015 - 14-feb-2016|