A pilot study into treating therapy resistant epilepsies using Nemos (cerbomed) confirms the initial, positive, intermediate results from June 2010. Nemos is the first device worldwide for transcutaneous vagus nerve stimulation (t-VNS). The study produced positive indications for safety, tolerability and effectiveness, along with verifying the high user-friendliness of t-VNS.
The prospective pilot study was carried out over nine months at the Epilepsy Centre of the University Hospital Erlangen, Germany. Patients, who for many years had suffered from drug-resistant epilepsy, used transcutaneous vagus nerve stimulation for more than three hours a day.
A decrease in the frequency and duration of hard to treat epileptic incidences was achieved for five of seven patients using transcutaneous vagus nerve stimulation. Hermann Stefan, director of the study, explained, “Altogether, transcutaneous vagus nerve stimulation can be judged as a safe and compatible method for long-term application. As such, it represents a possible therapy alternative for patients with hard to treat epilepsies.”
“The result of the pilot study is another important milestone for our company. It motivates us to carry out a worldwide, multicentre study for transcutaneous vagus nerve stimulation therapy from the middle of the year, and lays the foundation stone for a successful market launch,” said Jens Ellrich, chief medical officer, cerbomed.
Transcutaneous vagus nerve stimulation is an outpatient therapy and is carried out by the patient. The Nemos trancutaneous vagus nerve stimulator consists of a stimulation unit and an ear electrode used like an earphone. This electrode stimulates the auricular branch of the vagus nerve through the skin.