patients and family NEMOS for treatment of drug-resistant epilepsy

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1 patients and family NEMOS for treatment of drug-resistant epilepsy

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3 Transcutaneous Vagus Nerve Stimulation (t-vns ) with NEMOS the new treatment option No surgery Gentle and patient-friendly No hospitalization Minor side effects Autonomous treatment in everyday life

4 What is epilepsy? For a healthy person, the exchange of electrical and chemical signals between nerve cells in the brain is precisely coordinated. For patients who suffer from epilepsy, this coordination can get temporarily disturbed, resulting in pathological electrical discharges. Subsequent nerve cells then respond by sending sudden, uncontrolled signals, creating a sort of electrical storm in the brain. This spreads and activates individual brain areas or even the whole brain in an unnatural way. The symptoms and expressions of the resulting epileptic seizure depend on the areas affected. DIAGNOSIS Drug-resistant epilepsy Drug-resistant epilepsy is characterized by continued occurrence of seizures, despite appropriate treatment with drugs to treat epileptic seizures (anticonvulsive drugs). It affects more than 30 percent of patients with epilepsy. Few treatment options are currently available for these patients. These involve epilepsy surgery, deep brain stimulation and invasive vagus nerve stimulation.

5 Transcutaneous Vagus Nerve Stimulation a new therapy option Therapy option t-vns Transcutaneous Vagus Nerve Stimulation (t-vns ) uses the fact that a branch of the vagus nerve can be stimulated through the skin (transcutaneous) with electrical impulses, in areas of the outer ear. The vagus nerve is involved in the regulation of nearly all inner organs. Above all it affects areas of the brain which play a role in the onset, the course and the therapy of various neurological and psychiatric disorders. The stimulation of the vagus nerve passes along particular nerve fibers to reach the brainstem. As for invasive vagus nerve stimulation, this consecutively activates higher centers of the brain associated with an anticonvulsive (anti-seizure) effect (Fig. 1). This stimulation is carried out with the transcutaneous vagus nerve stimulator NEMOS. Fig. 1: Stimulus transmission via vagus nerve from the ear to the brain Site of stimulation Transmission of the excitation and activation of the brain Brainstem Auricular branch of the vagus nerve

6 NEMOS the transcutaneous vagus nerve stimulator PRINCIPLE OF OPEratION The transcutaneous vagus nerve stimulator NEMOS (Fig. above) consists of a stimulation unit and a dedicated ear electrode. The stimulation unit, having approximately the size of a common mobile phone, sends out the electrical impulses. It is connected with the ear electrode, which patients wear like an earphone (Fig. right). The impulses are transferred via the ear electrode through the skin to a branch of the vagus nerve.

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8 NEMOS more autonomy in everyday life Application The treatment with NEMOS is carried out autonomously by you as a patient in sessions lasting at least an hour, in 3 or 4 sessions a day, for a total of 4 to 5 hours per day. You can regulate and adapt the intensity of the stimulation (current intensity) according to your individual sensitivity, which can vary from day to day or even over the period of the therapy. It is important that the stimulation is noticeable, as a tingling sensation at the stimulation site. Using NEMOS does not involve surgery, or hospitalization. Basically, you can carry on with your usual everyday activities during the stimulation session, so NEMOS is easy to integrate into the daily routine.

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11 NEMOS the patient-friendly therapy Efficacy Most treatment options for drug-resistant epilepsy, like pharmaceuticals, deep brain stimulation and invasive vagus nerve stimulation, are no acute treatments. This also applies for NEMOS. Even if you respond to therapy with NEMOS, the effect generally occurs with a latency of some weeks to a few months. Like in all other therapies there can never be a guarantee of success for a treatment using NEMOS. It is possible that some patients will not respond sufficiently to the therapy. Such patients can return the device after 6 months, for a partial refund of the purchase price. Side Effects t-vns is a therapeutic alternative with minor side effects. An analysis of data from over 200 patients and volunteers, who participated in studies of t-vns, showed potential side effects that include itching, discomfort in the area of the outer ear and local pain at the stimulation side. These side effects usually disappear soon after stopping the stimulation. * * Vigilance data cerbomed GmbH

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13 Why NEMOS? No surgical risks t-vns -therapy with NEMOS provides targeted stimulation of the vagus nerve, without the risks of a surgical intervention. Minor side effects t-vns is a therapeutic alternative with minor side effects. Potential side effects usually disappear soon after stopping the stimulation. * Easy to use You can treat yourself with t-vns in your familiar environment. There s no need of a surgery or an inpatient stay. The menu-driven operation of the device is so simple that NEMOS can easily be integrated into the daily routine. * Vigilance data cerbomed GmbH

14 Frequently asked questions Am I suitable for t-vns therapy with NEMOS? We developed the NEMOS therapy for patients who suffer from drug-resistant epilepsy. You decide together with your consultant doctor whether this therapy is suitable for you. If your consultant doctor does not offer or know the therapy, please contact us. We will then contact your doctor, or can give you the details of a doctor who does offer this therapy. The NEMOS device is not certified for treating patients during pregnancy, or for patients with active implants (such as a cardiac pacemaker, or a cochlear implant).

15 ???????! How can I order NEMOS? If you decide, with your consultant doctor, to use the NEMOS therapy, you can order NEMOS directly from us (cerbomed GmbH). Further information is available on How much does NEMOS cost? Treatment with NEMOS is a private medical therapy, which is currently not covered by health insurance companies. Information on the price and financing options are available on request. Can I stop using medications if I decide to use t-vns? t-vns is a complementary therapy to medical treatment. Only your consultant doctor can decide whether you can stop or reduce medications. How often do I have to use NEMOS? The treatment with NEMOS is carried out autonomously by you as a patient in sessions lasting at least an hour, in 3 or 4 sessions a day, for a total of 4 to 5 hours per day. How long does it take until the effect of t-vns occurs? Most treatment options for drug-resistant epilepsy, like pharmaceuticals, deep brain stimulation and invasive vagus nerve stimulation, are no acute treatments. This also applies for NEMOS. Even if you respond to therapy with NEMOS, the effect generally occurs with a latency of some weeks to a few months.

16 How long do I have to use t-vns? Like most pharmaceutical and neuromodulatory treatments for drug-resistant epilepsy, t-vns is a long-term therapy. You will get further information from your consultant doctor. What can I do if I don t respond to t-vns? Like in all other therapies there can never be a guarantee of success for a treatment using NEMOS. It is possible that some patients will not respond sufficiently to the therapy. Such patients can return the device after 6 months, for a partial refund of the purchase price. When must NEMOS not be used? The NEMOS device is not certified for treating patients during pregnancy, or for patients with active implants (such as a cardiac pacemaker, or a cochlear implant). The device must not be used on wounds and diseased skin in the area of the electrodes. Further information about the therapy with NEMOS is available on

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18 This brochure is for information only. It does not substitute the instructions and explanations of a physician. Please contact your consultant doctor concerning questions with medical relevance or health issues. Please note that NEMOS is approved for the European market only. NEMOS is not cleared or approved for use in the U.S. cerbomed GmbH. All rights reserved.

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20 Further information is available on cerbomed GmbH Henkestrasse Erlangen Germany V201202EP_EN