Neurostimulation Implant Reduces Seizure Burden in Drug-Resistant Epilepsy

Traditional surgical options are invasive and can carry neurologic risk, limiting their use. Clinicians therefore need less invasive neuromodulation that can be targeted to the seizure focus while minimizing procedural burden. A new minimally invasive brain stimulation system now offers a patient-specific option delivered without opening the skull.

EASEE (Epicranial Application of Stimulation Electrodes for Epilepsy), developed by PRECISIS GmbH (Heidelberg, Germany), is designed for patients with drug-resistant focal epilepsy. The system uses a thin electrode positioned under the scalp and on top of the skull to deliver electrical pulses to the cortical region where seizures originate. The implant does not require opening the skull, does not contact brain tissue, and remains invisible beneath the skin, supporting a faster, lower‑risk procedure than traditional neurosurgical treatments.

A core component is a battery-powered Implantable Pulse Generator that incorporates energy-efficient electronics from Infineon Technologies to provide processing, data storage, and precisely targeted, patient-specific stimulation. Programming is individualized and set below each patient’s perception threshold so therapy can proceed without interrupting daily life. Development also prioritized data and device security alongside clinical performance.

The system is Investigational Device Exemption (IDE)-approved for a pivotal clinical trial in the United States and is commercially available in six European countries. The epicranial placement is described as lowering surgical risks compared with more invasive neurostimulation procedures and, unlike traditional epilepsy surgery, does not risk damaging brain tissue. The implantation technique is reported to be relatively simple for physicians to learn, enabling neurosurgeons to gain competence quickly.

Clinical studies have demonstrated safety and effectiveness in reducing seizure burden. Trial data showed a median seizure frequency reduction of 68% after two years of treatment, with four out of five patients choosing to continue therapy. At the two‑year follow‑up, almost two‑thirds of patients experienced fewer than half as many seizures as before treatment, and no serious adverse events related to the procedure or device were reported.

“This novel stimulation method has shown good efficacy, with low risks involved. If it doesn’t work for a particular patient, the device can easily be removed, and all the other, more invasive treatment options are still on the table. It makes sense for this approach to become the first-choice treatment for focal DRE,” said Michael Tittelbach, CTO and Managing Director at PRECISIS GmbH.

“We are already working on the next iteration of our technology,” said Tittelbach. “In the future, the device will both stimulate and sense. The electrode array will collect data that will help us control and improve upon how it delivers electrical stimulation. To do this, we’ll use AI and edge computing to monitor the device’s data output continuously.”

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