Meet Our Team
tVNS® E is currently the only transcutaneous, non-invasive vagus nerve stimulation device approved in Europe under the new Medical Device Regulation (MDR EU 2017/745). tVNS® E is explicitly approved for the indications epilepsy, chronic migraine, depression, and Prader-Willi syndrome.
Reduction in the average number of outbursts per day compared with the average number of outbursts per day in a phase before the intervention by at least 50% after 12 months of treatment.
Reduction of the depression-specific HAMD score by at least 2 to 3 points in adult patients when used alongside psycho-pharmacological and psycho-therapeutic treatments after 9 weeks of treatment.
Reduction in seizure frequency over a 28-day period during the intervention compared with the phase before the intervention by at least 25% after 20 weeks of treatment.
Reduction in the frequency of migraine days by 50% after 12 weeks of treatment.
We are proud that tVNS® is currently being investigated worldwide in various clinical and scientific contexts by high-profile research institutions. But where is the journey heading? Future developments aim to further improve application safety, personalisation, and integration into existing care concepts. The perspectives described below represent research and development directions and are not to be understood as clinical recommendations or approved applications.
Further development towards individualised neuromodulation. Current tVNS® applications mostly use predefined stimulation parameters. Future research approaches are examining whether an individual adaptation of frequency, intensity, and stimulation patterns is possible and meaningful.
Among other things, the following measurement methods are being evaluated:
The goal is better alignment of stimulation with individual neurophysiological differences, subject to corresponding clinical evidence and regulatory assessment.
Current tVNS® systems generally operate in an open-loop mode with fixed stimulation programmes. Research is investigating closed-loop approaches in which physiological signals could be used to dynamically adjust stimulation.
Possible control variables include:
These systems are still experimental and require comprehensive safety, clinical, and regulatory evaluation before any potential medical use.
Each year, more than 15 million people worldwide suffer a stroke. Many are left with weakness in the arm afterwards, making everyday tasks such as eating, dressing, or writing more difficult. Although rehabilitation therapy is a central component of stroke treatment, functional improvements are often limited. New approaches are therefore being investigated to specifically enhance the effects of rehabilitation.
Earlier studies have shown that stimulation of the vagus nerve during targeted movements can improve recovery of arm function after stroke. However, these studies used invasive vagus nerve stimulation (iVNS), in which a stimulator had to be surgically implanted. Stimulation could only be triggered in the clinical setting. The TRICEPS study is the first large-scale study to investigate whether this effect can also be achieved using a non-invasive method.
The main objective of the TRICEPS study is to examine whether tVNS® in combination with rehabilitation therapy can improve arm function after stroke more than rehabilitation alone.
In addition, it will assess:
In an accompanying sub-study, selected participants will undergo:
This will investigate whether tVNS® triggers neuroplastic changes in the brain that are associated with functional improvements in arm movement.
The TRICEPS study is one of the largest clinical trials of non-invasive vagus nerve stimulation in stroke rehabilitation.
It may provide important insights into:
