Vagus Nerve StimulationNCT06827548
Recording Cutaneous Vagal Nerve Activity With Multi-Electrode Array (MEA) in Patients Undergoing VNS Therapy
A study testing Multi-Electrode Array (MEA) Recording in people with Vagus Nerve Stimulation, run by Indiana University at 1 site in United States.
Trial summary
The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating vagal nerve function. This will be accomplished through several independent, but related, studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vagus Nerve Stimulation
- What is being tested?
- Multi-Electrode Array (MEA) Recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 13 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers with no GI symptoms
- Ages 18-80
- Undergoing VNS Therapy as part of clinical treatment for focal or partial epilepsy or seizure
- Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach
Who cannot join
- Unable to provide consent or has no LAR
- Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub I
- Taking medications affecting gastric motility
- Pregnant females
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hosptial
Indianapolis, Indiana, 46202
About this study
Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials - Phase 2
The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating vagal nerve function. This will be accomplished through several independent, but related, studies. The purpose of this study is to find out if it is possible to record compound nerve action potentials through the skin surface from participants who have previously had a vagus nerve stimulation device implanted as part of clinical care.
Read the detailed description
Participants who have an implanted cervical vagus nerve stimulation device (for the treatment of seizures) will be recruited. In a single study visit, investigators will attempt to record vagal nerve activity.
Cervical neck electrodes used in this part of the study will include the multi electrode array (MEA). The MEA can be placed on either side of the neck over the area of the vagus nerve to record any electrical activity that might occur during the baseline period.
Additionally, two ECG electrodes are placed either one on each arm or on the chest for measurement of the electrocardiogram (ECG). Three ECG electrodes are placed on the abdomen in a line parallel to the longitudinal axis of the stomach to record the electrogastrogram (EGG).
A onetime baseline recording will be made for 20 minutes after which the subject will be discharged from the study.
- Conditions
- Vagus Nerve Stimulation
- Being tested
- Multi-Electrode Array (MEA) Recording
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Electrode Array (MEA) RecordingDevice
Cervical neck electrodes used in this part of the study will include the multi electrode array (MEA). The MEA can be placed on either side of the neck over the area of the vagus nerve to record any electrical activity that might occur during the baseline period.
Additionally, two ECG electrodes are placed either one on each arm or on the chest for measurement of the electrocardiogram (ECG). Three ECG electrodes are placed on the abdomen in a line parallel to the longitudinal axis of the stomach to record the electrogastrogram (EGG).
A onetime baseline recording will be made for 20 minutes after which the subject will be discharged from the study.
| Study group | Role | What they receive |
|---|---|---|
| VNS Therapy Group | Experimental | Volunteers who do not have gastrointestinal symptoms and who are undergoing VNS Therapy as part of treatment for focal or partial seizure will be recruited for the study. Receives: Device: Multi-Electrode Array (MEA) Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Vagal Nerve Activation
The presence of a propagating nerve response at the volunteer's prescribed VNS parameter settings
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start26 May 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University
- Responsible party
- Principal investigator, Thomas V. Nowak, Indiana University
- Investigators
- Thomas V. Nowak, MD, Principal investigator, Professor of Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827548
- Sponsor's protocol ID
- 2006075899-B
- Status last verified
- Jul 2026
- First submitted
- 6 Dec 2024
- Last updated
- 14 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials - Phase 2
- ClinicalTrials.gov ID
- NCT06827548
- Acronym / sponsor ID
- 2006075899-B
- Conditions
- Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University
- Study start
- 26 May 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Posted 14 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating vagal nerve function. This will be accomplished through several independent, but related, studies. The purpose of this study is to find out if it is possible to record compound nerve action potentials through the skin surface from participants who have previously had a vagus nerve stimulation device implanted as part of clinical care.
Detailed description
Participants who have an implanted cervical vagus nerve stimulation device (for the treatment of seizures) will be recruited. In a single study visit, investigators will attempt to record vagal nerve activity.
Cervical neck electrodes used in this part of the study will include the multi electrode array (MEA). The MEA can be placed on either side of the neck over the area of the vagus nerve to record any electrical activity that might occur during the baseline period.
Additionally, two ECG electrodes are placed either one on each arm or on the chest for measurement of the electrocardiogram (ECG). Three ECG electrodes are placed on the abdomen in a line parallel to the longitudinal axis of the stomach to record the electrogastrogram (EGG).
A onetime baseline recording will be made for 20 minutes after which the subject will be discharged from the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VNS Therapy Group | Experimental | Device: Multi-Electrode Array (MEA) RecordingVolunteers who do not have gastrointestinal symptoms and who are undergoing VNS Therapy as part of treatment for focal or partial seizure will be recruited for the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteers with no GI symptoms
- Ages 18-80
- Undergoing VNS Therapy as part of clinical treatment for focal or partial epilepsy or seizure
- Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach
Key exclusion criteria (5 listed)
- Unable to provide consent or has no LAR
- Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub I
- Taking medications affecting gastric motility
- Pregnant females
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Electrode Array (MEA) RecordingCervical neck electrodes used in this part of the study will include the multi electrode array (MEA). The MEA can be placed on either side of the neck over the area of the vagus nerve to record any electrical activity that might occur during the baseline period. Additionally, two ECG electrodes are placed either one on each arm or on the chest for measurement of the electrocardiogram (ECG). Three ECG electrodes are placed on the abdomen in a line parallel to the longitudinal axis of the stomach to record the electrogastrogram (EGG). A onetime baseline recording will be made for 20 minutes after which the subject will be discharged from the study. | Device | VNS Therapy Group |
Primary outcome
Number of Participants With Vagal Nerve Activation
Time frame: 3 hours
The presence of a propagating nerve response at the volunteer's prescribed VNS parameter settings
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas V. Nowak, MD principal investigator
Professor of Clinical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Electrode Array (MEA) Recording in people with Vagus Nerve Stimulation, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Vagal Nerve Activation (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.