Status:
SUSPENDED
Systematic Evaluation of VNS Parameters
Lead Sponsor:
Duke University
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 stimula...
Detailed Description
This study will recruit adult participants with epilepsy who are undergoing planned surgery either for an initial implant of a vagus nerve stimulation (VNS) device or for replacement of their VNS impl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- patients with another implanted electrical device (besides VNS)
- a history of heart conditions that the surgeon considers a contraindication to study participation
Key Trial Info
Start Date :
November 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05395026
Start Date
November 28 2022
End Date
December 31 2025
Last Update
July 20 2025
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710