05-24-2012 07:56 PM CET - Health & Medicine
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Cerbomed GmbH: First patient included in the chronic migraine trial

Press release from: cerbomed GmbH

ERLANGEN/MUNICH, May 22nd, 2012 – The medical device company cerbomed GmbH, Erlangen, and the Headache Center of the Neurological Department at the Großhadern Hospital in Munich announce the inclusion of the first patient in the clinical trial for treating chronic migraine using transcutaneous Vagus Nerve Stimulation (t-VNS).
Under the supervision of Prof. Dr. med. Andreas Straube, the study will examine the effectiveness and safety of t-VNS in a randomized, double-blind study of 98 patients suffering from chronic migraine.

Migraine - a widespread disease
About 10% of the German population suffers from migraine, with women considerably more likely to be affected than men.
Chronic migraine is diagnosed for about 0.5% of Germans. The International Headache Society defines migraine as chronic if the patient suffers from headaches on more than 15 days per month, for more than 3 months.
"Patients with chronic migraine are severely restricted in their professional and private lives. Often medical prophylaxes, which are frequently associated with undesirable effects, do not bring about the desired decrease in migraine attacks. So it is all the more important to find new and effective therapy options which are only associated with minor side effects ", says Prof. Dr. Straube.
Prof. Dr. Straube is head of the Headache Center and president of the German Migraine and Headache Society.

Pain-killing effect of t-VNS
In cooperation with the Outpatient Department for Somatoform Disorders and Chronic Pain of the University of Regensburg, a randomized, controlled study addressed somatosensory pain processing. Prof. Dr. med. Jens Ellrich, Chief Medical Officer of cerbomed GmbH, explains why the new therapy option provided by t-VNS holds great promise: "In healthy subjects, using t-VNS resulted in a statistically significant reduction in mechanical pain perception, and a rise of the pressure pain threshold. It was the findings from this study that prompted us to carry out the clinical study for the therapy of chronic migraine with t-VNS".

About t-VNS
Transcutaneous Vagus Nerve Stimulation is addressed to patients suffering from various difficult to treat neurological and psychiatric diseases. The t-VNS therapy uses the fact that a branch of the vagus nerve is located directly under the skin in areas of the outer ear and therefore can be stimulated through the skin (transcutaneously) with electrical impulses.

About NEMOS
For t-VNS cerbomed developed and patented a special stimulator and a dedicated ear electrode. The stimulator, which is connected with the ear electrode, sends out the electrical impulses. With the transcutaneous vagus nerve stimulator NEMOS a targeted stimulation of the vagus nerve gets possible without the need of a surgery.
The German market entry for NEMOS is planned for the third quarter of 2012. NEMOS will then be available for patients suffering from difficult-to-treat epilepsies and depression.

Cerbomed GmbH is an innovative medical device company that concentrates on researching, developing and producing new technologies and products for neuromodulation. The company’s focus is on transcutaneous Vagus Nerve Stimulation (t-VNS), which may offer an attractive therapy option for patients with hard-to-treat neurological and psychiatric illnesses.
In 2011 cerbomed received the European clearance (CE mark) for the transcutaneous vagus nerve stimulator NEMOS. In early 2012 two clinical studies will be starting regarding the effectiveness of
t-VNS in patients with drug-resistant epilepsy and chronic migraine.

Please visit us on our new webpage www.cerbomed.com

cerbomed GmbH
Dr. Martin Hyca, Director Marketing
Henkestrasse 91
DE-91052 Erlangen

+49 9131 9202 76 30
martin.hyca@cerbomed.com

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