NCT05395026Completed
Systematic Evaluation of VNS Parameters
Systematic Evaluation of Vagus Nerve Stimulation Parameters on Cardiac Rhythm, Laryngeal Muscle Electromyography, and Vagus Nerve Activation in Acute and Chronic Implantations
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
The goal of this study is to measure the activation of the vagus nerve and the side effects of vagus nerve stimulation (VNS) (neck muscle contractions, changes in heart rate) across a range of stimulation parameters typically used in VNS therapy for epilepsy (pulse durations, pulse amplitudes, pulse repetition rates). This mapping of the parameter space may inform future device programming to improve electrical activation of the vagus nerve and/or to reduce side effects, and it may be used for validation of computational models. The study will recruit adult participants with epilepsy who are undergoing surgery either for an initial implant of a VNS device or for replacement of the implanted pulse generator (IPG) due to battery depletion. During surgery, the study will involve stimulating the vagus nerve via the standard implanted clinical VNS electrodes over a range of stimulation parameters while recording the activity of the vagus nerve (electroneurogram (ENG)), electromyogram (EMG) response of neck/throat muscles, and the heart rate (electrocardiogram (EKG)). Stimulation parameters will be within the ranges used for clinical therapy and below limits established for non-damaging electrical stimulation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 18 May 2022
- Start date
- 28 Nov 2022
- Primary completion date
- 23 Jul 2024
- Lead sponsor
- Duke University
- Diseases
- Epilepsy
- NCT number
- NCT05395026
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 28 Nov 2022 to the primary completion date, 23 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- a history of heart conditions that the surgeon considers a contraindication to study participation
Other
- patients with another implanted electrical device (besides VNS)
Who the study is looking for
- adult epilepsy patients undergoing VNS electrode implantation or implanted pulse generator (IPG) replacement surgery
- in good health
- neurologically stable aside from epilepsy
- able to provide informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
Related publications
- Intraoperative Laryngeal Muscle and Heart Rate Responses to Implanted Vagus Nerve Stimulation.Neuromodulation · 2026 · PMID 42024053
This page is information, not medical advice. Discuss any trial with your doctor.