epilepsy seizures
Conditions
Interventions
Clinical intracranial EEG monitoring (normally 7-10 days) will be prolonged for
two days, for systematic testing of different stimulation settings and their
effect on interictal epileptiform EEG act
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: - at least 16 years of age - potential central lobe epilepsy - on average 2 or more seizures per day or ongoing EPC - mentally and physically capable of giving informed consent - minimally 3 anti-epileptic drugs been admitted without effect on seizure frequency (refractory epilepsy)
Exclusion criteria
Exclusion criteria: - coagulopathy, including use of anticoagulant or antiplatelet agents - known allergy to the materials of the implant - progressive neurological or systemic disease - contra-indications to the presence of a chronically implanted device, such as the need for repeated MRI, or concurrent infections - any brain lesion that would place the patient at an elevated risk for bleeding - any progressive brain disease, e.g. Rasmussen*s encephalitis or glioma - presence of any active implanted metallic device, such as cardiac pace-maker, vagal nerve or deep brain stimulator, cochlear implants, spinal cord stimulator or metallic parts from non-medical origin - presence of aneurysm clips - SOZ outside eloquent cortex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean and maximum duration of the seizure-free interval, motor performance, and quality of life at the end of the study compared to these parameters prior to implantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Spectral content in a time window prior and post stimulation, number of interictal epileptiform discharges in a time window prior and post stimulation | — |
Countries
Netherlands
Outcome results
None listed