Epilepsy is one of the most common chronic neurological disease patterns and is associated with a high degree of impairment of quality of life. Despite a wide range of therapeutic approaches, almost one third of patients with epilepsy cannot benefit sufficiently from anticonvulsants. In order to achieve freedom from seizures with good tolerability, there is therefore an urgent need for alternative options. The bioelectronic stimulation procedure EASEE® is now pursuing completely new approaches in the treatment of epilepsy and is currently undergoing clinical testing. During a web conference chaired by Prof. Dr. Andreas Schulze-Bonhage, Medical Director of the Epilepsy Centre at the University Hospital of Freiburg, renowned experts confirmed the great potential of this innovative method. Conclusion: There are already many indications that EASEE® can trigger a paradigm shift in brain stimulation because it allows personalized treatment and does not require risky operations.

The drug therapy options for structural epilepsy are manifold, but the effectiveness is limited, as Prof. Dr. Andreas Schulze-Bonhage demonstrated. Approximately one third of those affected turn out to be drug refractory. Since only a small proportion of these patients are eligible for resective brain surgery, modern medical technology alternatives are urgently needed. Vagus nerve stimulation (VNS) and deep brain stimulation (DBS) are currently approved in Germany. Intracranial responsive focus stimulation (RNS) has proven to be effective in the long term, although it is not available in Europe. In addition, many patients shy away from the invasive procedure and its side effects.

EASEE® was developed for patients with focal epilepsy in whom drugs alone are no longer or only insufficiently effective and in whom brain surgery is out of the question for various reasons. As part of the gentler EASEE® implantation, a thin silicone mat with integrated platelet electrodes is placed minimally invasively under the scalp above the epileptic centre. The innovative electrode arrangement enables deep and focused stimulation of the brain from the outside – without touching it. To investigate the safety of the innovative procedure during implantation and during stimulation, 15 patients were enrolled in the currently ongoing EASEE II study. So far, no relevant side effects have been observed except for the expected transient local skin irritations. “The stimulation itself is just as uncomplicated and is not noticed by the patients,” summarized Prof. Dr. Andreas Schulze-Bonhage.

 

Positive experience reports on rapid and lasting effects

PD Dr. Yaroslav Winter, head of the Epilepsy Centre at the University Hospital in Mainz, has gained similar experience. He reported on two patients who both suffered from persistent seizures despite intensive pharmacological care. Both were presented with different options regarding resection, vagus nerve stimulation or inclusion in the EASEE-II study. The intracranial procedure and the VNS were rejected due to possible side effects, among other things. “Neither during nor after the implantation of EASEE® did complications or adverse effects occur”, reported PD Dr. Yaroslav Winter. “Above all, however, the good efficacy was convincing in both patients: Both the duration of attacks and the frequency of events were significantly reduced. One patient is currently even seizure-free. The positive effects could be observed quickly after activation of the stimulation and have been lasting for several months now”, concludes PD Dr. Yaroslav Winter.

 

Early intervention crucial for treatment success

In this context, Prof. Dr. Susanne Knake, head of the Epilepsy Centre Hesse at the University Hospital Marburg, once again emphasised the importance of effective intervention as early as possible: “If a patient is still not seizure-free even after the second monotherapy or after a combination therapy, pharmacoresistance and referral to an epilepsy centre should be considered accordingly. After all, with each additional drug treatment, the chances of seizure-freedom are only 5 to 10 % at most. With the VNS, DBS and other stimulation methods, she gave an overview of the different neurostimulation options used and tested in epilepsy therapy. According to this, there are good approaches, but there are still some hurdles to overcome. “It would be desirable to have a method that does not induce psychological side effects and is non-invasive and easy to handle,” said Prof. Dr. Susanne Knake. “Cosmetic aspects should also not be ignored completely. The more discreetly the implants can be placed, the higher the acceptance,” she continues, and places great hopes in the new bioelectronic stimulation procedure EASEE®.

 

PIMIDES – a further step towards individualized neurostimulation

Prof. Dr. Soheyl Noachtar, head of the interdisciplinary epilepsy center at the Ludwig-Maximilians-University of Munich, presented the so-called PIMIDES study – the follow-up study of the EASEE II study – during the event. Here, too, the effects on seizure frequency, seizure severity and quality of life of the study participants are to be observed. In addition to an automatically applied periodic stimulation sequence, patients in this study have the option of requesting targeted stimulation as soon as they perceive the onset of a seizure. The duration and intensity of the bolus can be individually adjusted. “This option allows neurostimulation with EASEE® to be adapted even more specifically to the needs of the patients,” emphasized Prof. Dr. Soheyl Noachtar. The PIMIDES study is running in seven European centers and is expected to define a further milestone in the use of artificial intelligence to control individualized neurostimulation.

 

About Precisis AG

Precisis AG was founded in 2004 and is a company that specialises in the development of innovative medical devices, with its headquarters in Heidelberg.
Precisis AG is a byword for outstanding success in the field of instrument-controlled therapies for the brain. We are committed to progress and are developing individually tailored, precise treatment methods in the field of neurostimulation, to improve the lives of seriously ill patients. Ethical considerations and responsible handling of the complex technical options are naturally deeply rooted in the approach taken by our staff. Reliable solutions for people with functional brain disorders are hereby being developed in collaboration with strong partners.
EASEE® is an acronym for “Epicranial Application of Stimulation Electrodes for the treatment of Epilepsy”.

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