Project to evaluate the short-term effects of visceral osteopathic vagus nerve stimulation in humans
- Conditions
- G40.9Epilepsy, unspecified
- Registration Number
- DRKS00029914
- Lead Sponsor
- niversitätsklinikum Bonn
- Brief Summary
on-invasive transcutaneous vagus nerve stimulation elicits similar therapeutic effects as invasive vagus nerve stimulation, offering a potential treatment alternative for a wide range of diseases, including epilepsy. Here, we present a novel, non-invasive stimulation of the vagus nerve, which is performed manually viscero-osteopathically on the abdomen (voVNS). We explore the impact of short-term voVNS on various local and global characteristics of EEG-derived, large-scale evolving functional brain networks from a group of 20 subjects with and without epilepsy. We observe differential voVNS-mediated alterations of these characteristics that can be interpreted as a reconfiguration and modification of networks and their stability and robustness properties. Clearly, future studies are necessary to assess the impact of such a non-pharmaceutical intervention on clinical decision-making in the treatment of epilepsy. However, our findings may add to the current discussion on the importance of the gut-brain axis in health and disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 25
Patients for whom continuous EEG recording is required as part of clinical care
- Patient age =18 years
- Interest in participation
- Willingness/consent to participate
- Patients with implanted vagus nerve stimulator (VNS), deep brain stimulator (DBS).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The statistical moments of the distributions of the temporally resolved parameters are then subjected to various statistical tests in order to identify possible influences of the activation procedure on global and local network properties in the group as well as in individual cases. For this purpose, both the absolute parameters and relative changes (with respect to the individual mean level calculated from the data before and after stimulation) will be considered. Since little is known about stimulation-induced network modifications, an interpretation of the possibly altered network characteristics (e.g., in terms of graph-theoretical concepts) remains difficult for the time being. If necessary, network surrogate concepts should be used to further substantiate the value of observable network modifications.<br>Duration of the study approx. 3 h, evaluation of the network parameters before/during, after the intervention, within this period.
- Secondary Outcome Measures
Name Time Method