Press release - April 30th, 2015
Trial results for transcutaneous Vagus Nerve Stimulation in pharmacoresistant epilepsy: Cerbomed GmbH at the 9th Dreiländertagung in Dresden
ERLANGEN/DRESDEN, 30th April 2015 – At the 9th annual joint conference of the three German-speaking regions of the International League Against Epilepsy in Dresden, the results of a trial on transcutaneous Vagus Nerve Stimulation (t-VNS) in pharmacoresistant epilepsy were presented for the first time.
Trial shows reduction in seizures with t-VNS
In the multi-centre, randomised, controlled, 2-arm, double-blind study, 76 adult epilepsy patients from Germany and Austria were treated over 5 months with t-VNS. The affected patients presented with various epilepsy syndromes and had at least three seizures per month.
The trial showed that patients tolerated the treatment very well. With an average of 93%, participants‘ therapeutic compliance was excellent. After 5 months the seizure rate reduced by 23% on average with 25 Hz stimulation.
Quality of life increased significantly in both treatment groups.
The side effects were very mild and quickly resolved after discontinuing stimulation.
When these outcomes are compared with those from studies on invasive Vagus Nerve Stimulation (iVNS), the efficacy of t-VNS and iVNS is shown to be comparable.
“The results of the trial show that transcutaneous Vagus Nerve Stimulation is well tolerated and may lead to an increased quality of life. Due to the high tolerability, this type of treatment may be used early on as an adjunct to drug therapy,” according to Dr. Andreas Hartlep, CEO of cerbomed GmbH.
About t-VNS with NEMOS
Transcutaneous Vagus Nerve Stimulation with NEMOS offers a further therapy option to epilepsy patients, who suffer from continued occurrence of seizures, despite appropriate treatment with anticonvulsive drugs.
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.
The treatment with NEMOS is carried out autonomously by the patients by using the therapy device NEMOS, a special stimulator and a dedicated ear electrode, that sends out the electrical impulses. With NEMOS a targeted stimulation of the vagus nerve gets possible without the need of a surgery.
Cerbomed GmbH is an innovative medical device company located in Erlangen, Germany, that focuses on neuromodulation. The company, founded in 2005, focuses on transcutaneous Vagus Nerve Stimulation (t-VNS), which may offer an attractive therapy option for patients with hard-to-treat neurological and psychiatric illnesses.
The transcutaneous Vagus Nerve Stimulation received the European clearance (CE mark) for the treatment of epilepsies, depression and pain. Two clinical studies regarding the effectiveness of
t-VNS in patients with drug-resistant epilepsy and chronic migraine have been finished in 2014.