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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 is a NA study that has completed, run by Duke University. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05395026
The ClinicalTrials.gov registry entry for NCT05395026 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which electrical stimulation of vagus nerve is the first listed.
NCT05395026 reports 0 study locations.
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.
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