Innovative neurostimulation method persuasive among the first focal epilepsy patients
Basel/Heidelberg, May 24, 2019 – Some 30% of all epilepsy patients cannot be treated satisfactorily despite a wide range of medication options. The condition restricts the people affected severely. To increase the chance of better epilepsy control and thus better quality of life, the new EASEE®stimulation method is currently being tested in the so-called clinical phase following successful preclinical trials. The first implantations have already been carried out successfully. In the run-up to this year’s Annual Meeting of the German and Austrian Society for Epileptology and the Swiss Epilepsy League, renowned experts discussed the restrictions epilepsy patients have in everyday life, the limits of current treatment options and the opportunities EASEE®can offer for patients with drug-resistant focal epilepsy.*
Epilepsy is one of the world’s most common chronic conditions. Patients often have a long path ahead of them before receiving the right diagnosis. “Every third patient does not respond adequately to the medication options currently available,” said Professor Andreas Schulze-Bonhage, Medical Director of the Epilepsy Center at the University Medical Center Freiburg. “Patients are often severely restricted in their quality of life. In addition to necessary adjustments in recreational behavior, certain professions cannot be pursued. High-dosage medication often entails tolerability issues, in particular cognitive impairments and teratogenicity issues,” Professor Andreas Schulze-Bonhage continues. “One additional option is resective epilepsy surgery, which can achieve good results in some cases but is only available to an extremely small group of patients,” said the Freiburg epileptologist. Existing stimulation methods such as vagus nerve or thalamic stimulation can affect certain symptoms of epilepsy but this advantage is offset by tolerability issues.
EASEE®: Epicranial stimulation electrodes for the treatment of epilepsy
“The highly innovative EASEE®stimulation system is classified as a Class III Active Implantable Medical Device (AIMD). It can reach the epileptic focus of the specific patient’s brain accurately and treat it permanently,” explained Michael Tittelbach, Chief Technical Officer at Precisis AG in Basel. For optimum stimulation, two clinically successful electrical stimulation methods – AC stimulation and ULFA stimulation – are combined to deliver some 700 pulse sequences per day. “Since the central electrode of the electrode pad can be polarized either as an anode or as a cathode, the treatment of other functional cerebral diseases is also theoretically possible,” Michael Tittelbach continues. The therapeutic pulses can be adapted for each patient with this neuromodulation method. EASEE®is an individualized system with learning capabilities in which optimizations can be regularly made over the duration of the treatment.
“The implantation of EASEE®takes no longer than 30 to 45 minutes,” said Doctor Martin Glaser, senior physician at the Neurosurgical Center at the University Medical Center Mainz. The thin silicone pad with integrated platelet electrodes is placed beneath the scalp and over the area of the brain exhibiting the epileptic activity with anatomical precision in a minimally invasive procedure. The cranium remains completely intact. “The thin platelet electrodes of the full implant are not externally visible and guarantee unrestricted freedom of movement for patients,” explained the neurosurgeon. “Of all the neuromodulation methods, EASEE®is the simplest and least invasive procedure for patients in terms of implantation technique,” commented Doctor Martin Glaser.
Promising: The first implantations confirm expectations
“In particular, patients with an inadequate response to antiepileptic drugs and for whom surgical intervention is not an option or who reject it should benefit from EASEE®in our opinion,” says Professor Andreas Schulze-Bonhage, head of the EASEE®II study. The first of the 15 prospective patients were included in the study in the last few months. The first patient has already noticed positive changes: “I am doing well with it. I am already noticing a positive effect in that subjectively the duration of a seizure seems shorter. The period until I have complete control over my language after a seizure is also shorter,” said Sophie Kaiser**. In addition to an improved quality of life, the effects on the frequency and severity of seizures, epileptic activity in the EEG, quality of life, mood and cognition are recorded and analyzed within the framework of current studies.
During the event, Professor Christoph Helmstaedter, head of the Neuropsychology Department at the Clinic and Polyclinic for Epileptology at Bonn University Hospital, explained that stimulation methods can also have a positive effect on mood and cognition. “Several studies were able to prove the close and, in some instances, reciprocal relationship between epilepsy and cognition and behavior,” says the expert. Patients could benefit in three ways: first, by controlling the disruptive epilepsy; second, by reducing the medication burden; third, by the stimulation itself. “It therefore remains exciting to see what will still be possible with EASEE®as a treatment option in terms of improving the brain function and quality of life of patients with functional cerebral diseases,” concluded Professor Christoph Helmstaedter.
* Source: Make living with epilepsy easier – EASEE®Innovation Forum of Precisis AG on May 7, 2019 in Basel, Switzerland.
** First and last name of patient changed, pseudonym.
About Precisis AG
Precisis AG was founded in 2004 and is a company that specializes in the development of innovative medical products with registered office in Heidelberg.
Precisis AG stands for outstanding successes in the field of therapies for the brain that are controlled by apparatuses We are committed to progress and develop individualized and precise treatment methods in the field of neurostimulation to make life easier for seriously ill patients. An ethical and responsible approach to the complex technical possibilities is deeply rooted in our employees’ identity. In cooperation with some strong partners, we are therefore able to provide reliable solutions for people with functional cerebral diseases.
EASEE®stands for ‘Epicranial Application of StimulationElectrodes for Epilepsy’.
Further information about the activities, progresses, and milestones in the history of Precisis AG can be found on our website: www.precisis.de.
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