Systematic Evaluation of VNS Parameters

Completed · Not applicable

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT05395026

Run by

Duke University

People needed

16

Starts

2022-11-28

Expected to finish

2024-07-23

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• patients with another implanted electrical device (besides VNS)
• a history of heart conditions that the surgeon considers a contraindication to study participation

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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