Epilepsy is among the most prevalent neurologic disorders and affects around 1% of the global population. Despite the availability of new antiseizure medications (ASMs), over a third of epilepsy patients fail to respond to drug therapy, particularly those with focal epilepsy, and many are not candidates for epilepsy surgery. Therefore, alternative treatment strategies are necessary. Focused cortical stimulation is an innovative procedure that provides a novel approach to treating epileptic seizures and favorably influencing the course of the disease for patients with inoperable forms of focal epilepsy. Now, the world’s first minimally invasive brain pacemaker utilizes a pioneering procedure that uses subcutaneous electrodes positioned outside the cranium to suppress epileptic seizures in patients with focal epilepsy that is resistant to drug therapy.

Precisis GmbH (Heidelberg, Germany) has developed EASEE (Epicranial Application of Stimulation Electrodes for Epilepsy), a system for individualized brain stimulation, which is implanted under the scalp, specifically over the epileptic focus in the brain, without opening the cranial bone or touching the brain tissue. EASEE functions through a dual mode of action: high-frequency pulses every two minutes provide an acute, disruptive effect to prevent seizures, while a 20-minute daily application of continual current regulates hyperactive brain regions in the long term.

The unique miniaturization of bioelectric pacemakers for the brain has made them highly tolerable, with patients accepting them as a natural part of their body. The slim electrodes are not visible externally and provide consistent support to the patient, acting as a safeguard against transmission malfunctions in the brain. The innovative electrode design allows for deep and precise brain stimulation, without any direct contact with the brain itself. EASEE is custom-placed for each clearly defined neocortical focus, using a minor surgical procedure under general anesthesia. During the procedure, a wafer-thin electrode pad is implanted beneath the scalp, and a pulse generator is implanted in the chest area, connected to the electrode pad by a cable.

The EASEE system has been tested for safety and effectiveness in adult patients with focal epilepsy in various European study centers. In the most recent meta-analysis of two identical studies, which included a total of 33 patients from seven European epilepsy centers, EASEE was implanted in a prospective non-randomized trial format for an eight-month evaluation period. Following six months of active treatment, 53% of patients showed a complete response to the device, defined as a reduction in seizure frequency of at least 50% below baseline. Additionally, 84% of patients demonstrated some form of response. There were no serious adverse events reported that were linked to either the device or its implantation.

“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,” said Principal Investigator Professor Andreas Schulze-Bonhage, Head of the Epilepsy Centre at University Hospital. “An effective reduction in seizure frequency suggests that focal cortex stimulation represents a promising treatment option for patients with a predominant epileptical focus.” 

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