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NCT05395026 · ClinicalTrials.gov registry record · NA
Systematic Evaluation of VNS Parameters
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT05395026: Completed NA study, sponsored by Duke University.
NCT05395026 is a NA study that has completed, run by Duke University. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05395026, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The stimulation amplitude threshold is the amplitude when vagus nerve stimulation (VNS) activates the laryngeal muscles and has potential to cause subject discomfort during stimulation. The stimulation amplitude threshold will be measured with the NIM-EMG endotracheal tube recording, and the threshold will be determined as the amplitude that causes the first evoked potential in the laryngeal muscles.
Interventions
- OTHER electrical stimulation of vagus nerve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2024-07-23 |
| Phase | NA |
What the finished NCT05395026 record still lists
NCT05395026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which electrical stimulation of vagus nerve is the first listed.
NCT05395026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05395026 about?
NCT05395026 is a clinical study titled "Systematic Evaluation of VNS Parameters". 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...
What is the current status of trial NCT05395026?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2022-11-28. Estimated completion is 2024-07-23.
What interventions are being tested in trial NCT05395026?
The interventions under investigation include: electrical stimulation of vagus nerve (OTHER).
Who is sponsoring clinical trial NCT05395026?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05395026's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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