Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
30 participants
INTERVENTIONAL
2022-11-28
2026-12-31
Brief Summary
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Detailed Description
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The research study will take place during VNS surgery. For participants undergoing a first VNS implant surgery, once the vagus nerve is exposed and before placing the VNS electrodes, the investigators may image the nerve with ultrasound. Mapping of the parameter space will then occur after placement of the cuff electrodes around the cervical vagus nerve for participants undergoing a first VNS implant surgery or removal of the IPG with the depleted battery for patients undergoing IPG replacement surgery. Temporary sterile extension wires will connect the implanted VNS electrode to the research stimulation system. Research procedures will involve stimulating the vagus nerve through the standard implanted clinical VNS electrodes over a range of stimulation parameters. At the same time, the investigators will record how changes in stimulation affect the activity of the vagus nerve (measured by electroneurogram (ENG)), the response of the neck and throat muscles (by electromyogram (EMG)) and the heart rate (by electrocardiogram (EKG)). Several stimulation trials will be conducted with different VNS parameters (pulse duration, pulse amplitude, and pulse repetition rate) delivered in randomized order. Stimulation parameters will be within the ranges used for clinical therapy and will not exceed those that produce a 25% reduction in heart rate. Measurements will be made during 10 to 60 second trials, in which stimulation will be off for the first section (baseline), on for the second section (responses to stimulation), and off for the final section (recovery). The stimulus waveform will be a charge-balanced biphasic pulse, with values of charge density (D) limited to values below the nondamaging limits that are well-established in literature.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Investigational Stimulation Parameters
electrical stimulation of vagus nerve
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.
Interventions
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electrical stimulation of vagus nerve
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.
Eligibility Criteria
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Inclusion Criteria
* in good health
* neurologically stable aside from epilepsy
* able to provide informed consent
Exclusion Criteria
* a history of heart conditions that the surgeon considers a contraindication to study participation
18 Years
65 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Warren M Grill, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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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.
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.
Other Identifiers
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Pro00103473
Identifier Type: -
Identifier Source: org_study_id
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