REC2Stim as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.
REC2Stim as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.
People with central lobe epilepsy (CLE), with seizures arising from the primary sensorimotor
 cortex, typically show a high rate of convulsive seizures that do not respond to
 anti-epileptic drugs, but have a large impact on quality of life. They often seek surgical
 relief, but since the area contains the body's indispensable sensorimotor representation, CLE
 surgery will lead to permanent functional deficits. Cortical stimulation case studies in CLE
 have shown seizure frequency reduction of more than 90%, but in our experience, stimuli in
 the central lobe can hardly be applied without interfering with motor function.

 The investigators propose cortical electrical stimulation therapy of a conceptually novel
 type. The investigators systematically determine individual stimulation settings, stimulation
 site and a seizure detection algorithm. In REC2Stim (Rational Extra-eloquent Closed-loop
 Cortical Stimulation), at the start of a seizure, a train of electric pulses is delivered to
 a nearby extra-eloquent area connected with the epileptogenic area within the sensorimotor
 cortex. Success will constitute a therapeutic modality for pharmaco-resistant patients with
 an epileptic focus in eloquent areas.
The investigators will include ten patients with CLE, aged 16 years and older, in whom
 pre-surgical chronic intracranial EEG monitoring has revealed a seizure onset in the primary
 sensorimotor cortex. Patients should have on average at least two seizures per day.

 Clinical intracranial EEG monitoring (normally 7-10 days) will be extended with two extra
 monitoring days, for systematic testing of different stimulation settings and their effect on
 interictal epileptiform EEG activity (as a surrogate marker for ictal epileptiform activity),
 from which site and parameters for chronic stimulation will be determined.

 Upon removal of the clinically implanted electrodes, a neurostimulator with sensing
 capabilities, Activa PC+S, will be implanted and attached to two subdural leads with
 electrodes covering the predefined stimulation site and the eloquent epileptogenic area.

 During a data collection phase, stimulation-free data will then be collected to train the
 seizure detection algorithm up to at least 50% sensitivity.

 Finally, the REC2Stim phase will be started, in which cortical stimulation is applied when
 seizure activity is detected. Study participation is one year. When REC2Stim turns out
 effective in month 10 and 11 after implantation of the neurostimulator, 2 weeks of sham
 stimulation will follow in month 12.
Inclusion Criteria:

 -  potential central lobe epilepsy

 -  on average 2 or more seizures per day or ongoing Epilepsia Partialis Continua (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:

 -  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

 -  seizure onset zone (SOZ) outside eloquent cortex