NCT05395026

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 28, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2024

Completed
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

May 18, 2022

Last Update Submit

March 5, 2026

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • stimulation amplitude threshold

    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.

    During procedure (30 minutes)

Study Arms (1)

Investigational Stimulation Parameters

EXPERIMENTAL
Other: electrical stimulation of vagus nerve

Interventions

electrical stimulation of vagus nerveOTHER

VNS electrical stimulation parameters (pulse duration, pulse amplitude, and pulse frequency) will be systematically changed to determine the effect on vagus nerve activation, laryngeal muscle contraction, and heart rate.

Investigational Stimulation Parameters

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

  • Cogan SF, Ludwig KA, Welle CG, Takmakov P. Tissue damage thresholds during therapeutic electrical stimulation. J Neural Eng. 2016 Apr;13(2):021001. doi: 10.1088/1741-2560/13/2/021001. Epub 2016 Jan 20.

    PMID: 26792176BACKGROUND

  • Kumsa D, Steinke GK, Molnar GF, Hudak EM, Montague FW, Kelley SC, Untereker DF, Shi A, Hahn BP, Condit C, Lee H, Bardot D, Centeno JA, Krauthamer V, Takmakov PA. Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters. Neuromodulation. 2018 Feb;21(2):117-125. doi: 10.1111/ner.12641. Epub 2017 Aug 7.

    PMID: 28782181BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Warren M Grill, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 27, 2022

Study Start

November 28, 2022

Primary Completion

July 23, 2024

Study Completion

July 23, 2024

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)