Epilepsy Intractable Clinical Trial
Official title:
Rational Extra-eloquent Closed-loop Cortical Stimulation (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.
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