New Data on Focused Cortical Stimulation for Drug-Refractory Focal Epilepsy
Favorable results for a novel neurostimulation device used to treat individuals with drug refractory focal epilepsy have been reported in a recent issue of JAMA Neurology. According to the study, over 53% of individuals treated with a device providing epicranial focal cortex stimulation (EASEE System; Precisis GmbH, Heidelberg, Germany) experienced at least 50% reduction in the number of seizures reported compared with their baseline after 6 months of treatment (95% CI, 0.37%-0.76%; P<.001). In terms of other outcomes, there were no improvements seen in self-reports of mood over the study period, although a slight improvement in cognitive scores was reported (mean change in EpiTrack scores +1.3, P<.1)
No statistically significant serious adverse events related to the device or the implant procedure were reported.
This study pooled and analyzed data from 2 prospective, interventional, unblinded multicenter pilot studies: 1) A Pilot Study to Assess the Feasibility of Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (EASEE II) and 2) A Pilot Study to Assess the Feasibility of Patient-Controlled Neurostimulation With the EASEE System to Treat Medically Refractory Focal Epilepsy (PIMIDES I). Participants (n=34) were included if they were 18 to 75 years old, had focal-onset seizures uncontrolled by at least 2 antiseizure medications, had at least 3 seizures a month, and had a predominantly temporolateral or extratemporal epileptic focus. Patients were excluded if they were diagnosed with primary generalized epilepsy or mesiotemporal epilepsy. The study took place at 7 European epilepsy centers.
After gathering baseline data for 1 month, participants in the studies were implanted with a neurostimulation system that included a pulse generator and a stimulation electrode. The stimulation electrode was implanted epicranially above the patient’s epileptic focus region and was connected to the pulse generator, which was placed subcutaneously in the pectoral area. The device was first activated 1 month after placement. Participants completed a series of standard research instruments to determine mood, quality of life changes, and seizure severity at baseline and during the study period.
Limitations of these studies include the lack of control groups and the small sample size. EASEE is an abbreviation for Epicranial Application of Stimulation Electrodes for Epilepsy.
“Results from this groundbreaking study suggest that focal cortex stimulation with an epicranial electrode array may offer a safe and effective new treatment option for patients with drug-refractory focal epilepsy”, commented Principal Investigator Professor Andreas Schulze-Bonhage, Head of the Epilepsy Centre at University Hospital, Freiburg, Germany.