temporal lobe epilepsy (TLE)/ epilepsy with the focus in one particular part of the brain
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Investigational group: - Diagnosis of pharmacoresistant temporal lobe epilepsy (TLE), based on clinical evaluation and (video-) EEG (electro-encephalography) - Age between 18-60 years - Normal liver function tests - Normal full blood count - Weight >50 kg - All subjects have to be willing and able to give informed consent (written);If necessary, healthy volunteers will be included: - Age between 18-50 years - Good physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests - Weight >50 kg - RDC (Research Diagnostic Criteria) diagnosis never mentally ill - Written informed consent of each subject
Exclusion criteria
Exclusion criteria: - Any clinical significant abnormality of any clinical laboratory test - Any subject who has received any investigational medication within 30 days prior to the start of this study, or who is scheduled to receive an investigational drug - Any subject who has been prescribed a benzodiazepine preparation within 1 month prior to the start of this study - Major psychiatric or neurological disorder other than temporal lobe epilepsy (TLE) with or without a known substrate - History of alcohol and/or drug abuse (DSM-IV criteria) - History of coagulation problems - Any sign of cardiovascular disease including new abnormalities on ECG - Use of non-steroid anti-inflammatory drugs or drugs known to interfere with the P-gp, other than anti epileptic drugs (AEDs) - Abnormalities on MRI other than temporal localised pathology (i.e. mesial temporal sclerosis, tumor) that is the cause and/or effect of the TLE, and/or abnormalities on MRI other than white matter changes or an incidental small lacunar lesion without clinical diagnosis - Blood donation or substantial blood loss within 3 months before the scan day - Metal objects in or around the body (braces, pacemaker, metal fragments) - Use of antithrombotics and acetylsalicylacid (ASA) - Unable to understand or read the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The influence of P-gp function at the BBB on flumazenil binding to the GABAA-receptor in pharmacoresistant patients with TLE. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) The effect of tariquidar on the cerebral blood flow (CBF). If there is an effect of tariquidar on CBF: (2) The effect of blood flow in the brain on [11C]flumazenil uptake. 1) Effect of blood flow in the brain on [11C]flumazenil uptake. If flumazenil is a substrate for P-gp: (3) Quantification of the upregulation of P-gp by TLE, by comparing pharmacoresistant patients with TLE with healthy volunteers. | — |
Countries
Netherlands
Outcome results
None listed