GastroparesisABVN2NCT07881289
ABVN Phase 2 - Vagal Maneuvers
A study testing Vagal Maneuvers in people with Gastroparesis, run by Indiana University at 1 site in United States.
Trial summary
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators want to evaluate the effects of noninvasive stimulation of the auricular branch of the vagal nerve (ABVN) on vagal nerve function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Vagal Maneuvers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 25 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
- Aged 18-80 years
- Willing to perform vagal activity maneuver (Vagal arm)
Who cannot join
- Have an implanted gastric stimulator
- Unable to provide consent
- Pregnant females
- Prisoners
Trial locations and contacts
1 site in 1 country.
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 - Vagal Maneuvers
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators want to evaluate the effects of noninvasive stimulation of the auricular branch of the vagal nerve (ABVN) on vagal nerve function.
The purpose of the ABVN Phase 2 grant is to expand on previous work evaluating vagally mediated compound nerve action potentials (CNAPs). This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of vagal stimulation through simple physical techniques (vagal maneuvers) in subjects with gastroparesis.
[This study was originally described in NCT06491758, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 2 grant.]
Read the detailed description
Patients with gastroparesis will be recruited for this project, which is expected be completed over approximately 3 hours. If all procedures cannot be completed in a single visit, participants may return on a second day to complete them.
When participants arrive, electrodes are placed over the right and left vagus nerve (to record vagal nerve activity), chest (to record electrocardiogram, or ECG) and stomach area (to record electrogastogram, or EGG). A 10 minute baseline recording of vagal nerve activity, electrocardiogram (ECG) and electrogastrogram (EGG) is then completed prior to beginning the vagal maneuvers.
Participants may be asked to perform any of the following maneuvers:
- Cough: Each subject will be asked to generate approximately 6 to 8 forceful and sustained coughs over 5 to 10 seconds.
- Cold stimulus to face: An ice pack or a washcloth soaked in ice water will be placed on each subject's face for about 10 seconds to mimic the physiological response of being submerged in cold water (Diver's Reflex)
- Carotid Massage: This technique is performed with the subject's neck in an extended position with the head turned away from the side being massaged. Only one side is massaged at a time. Pressure is applied underneath the angle of the jaw in a gentle circular motion for about 10 seconds. The subject is monitored throughout.
- Gagging: A tongue depressor is briefly inserted into the subject's mouth touching the back of the throat, which causes the person to reflexively gag.
- Valsalva maneuver: The subject is instructed to bear down as if they were having a bowel movement. The subject is asked to blow through a mouthpiece that is hooked to a device used in clinical spirometry until the pressure reaches 10mmHg.Alternatively, we can have the subject blow through the barrel of a 10 ml syringe for 15-20 seconds. This maneuver increases intrathoracic pressure and stimulates the vagus nerve.
After performing a maneuver for 10 seconds, another 8 minutes of recording will be made before doing any additional maneuvers.
Participants may also be asked to perform one or more eating maneuvers after an overnight fast.
- Eating: After 20 minutes of baseline recordings, subjects will be asked to drink 8 ounces of either water or Ensure Original. After the fluid is consumed, an additional 20 minutes of recordings will be made.
Maneuvers will be selected at the investigator's discretion and not all maneuvers will be completed. If both the water and Ensure eating maneuvers are selected, they will be completed at two separate visits.
- Conditions
- Gastroparesis
- Being tested
- Vagal Maneuvers
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal ManeuversOther
Subjects will be asked to perform various maneuvers to stimulate the vagus nerve:
- Cough: Produce 6 to 8 forceful coughs over 5 to 10 seconds
- Cold stimulus to face: Have an ice cold washcloth placed on their face for 10 seconds.
- Carotid massage: While the neck is extended and the head turned away from the side being massaged, pressure is applied underneath the angle of the jaw in a gentle circular motion for about 10 seconds.
- Gagging: a tongue depressor is briefly inserted into the mouth touching the back of the throat.
- Valsalva maneuver: subjects will will be asked to bear down as if they were having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a machine that measures how hard they are blowing. Alternatively, they can blow through the barrel of a 10 ml syringe for 15-20 seconds.
- Eating: Subjects will be asked to drink 8 ounces of water and/or Ensure Original after fasting overnight
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis Subjects | Experimental | Subjects with a confirmed diagnosis of gastroparesis. Receives: Other: Vagal Maneuvers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of vagal nerve compound action
To measure the amplitude of vagal nerve compound action potentials during vagal maneuvers.
Measured: 3 hours
Respiratory Changes in heart rate during stimulation
To measure respiratory changes in heart rate during vagal maneuvers.
Measured: 3 hours
Changes in amplitude of the surface electrogastrogram
To measure the changes of surface electrogastogram during vagal maneuvers.
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 posted19 Oct 2026
- Study start24 Nov 2020
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Thomas V. Nowak, Indiana University
- Investigators
- Thomas V Nowak, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881289
- Sponsor's protocol ID
- 2006075899-C
- Other IDs
- 1OT2OD028183-01
- Acronym
- ABVN2
- Status last verified
- Aug 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with other researchers for similar purposes as to this study
Study at a glance
From the registry record, last updated by the sponsor on 19 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 - Vagal Maneuvers
- ClinicalTrials.gov ID
- NCT07881289
- Acronym / sponsor ID
- ABVN2 / 2006075899-C
- Conditions
- Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, National Institutes of Health (NIH)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators want to evaluate the effects of noninvasive stimulation of the auricular branch of the vagal nerve (ABVN) on vagal nerve function.
The purpose of the ABVN Phase 2 grant is to expand on previous work evaluating vagally mediated compound nerve action potentials (CNAPs). This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of vagal stimulation through simple physical techniques (vagal maneuvers) in subjects with gastroparesis.
[This study was originally described in NCT06491758, however a separate record has been created to more accurately reflect the independence of the individual studies supported by the ABVN 2 grant.]
Detailed description
Patients with gastroparesis will be recruited for this project, which is expected be completed over approximately 3 hours. If all procedures cannot be completed in a single visit, participants may return on a second day to complete them.
When participants arrive, electrodes are placed over the right and left vagus nerve (to record vagal nerve activity), chest (to record electrocardiogram, or ECG) and stomach area (to record electrogastogram, or EGG). A 10 minute baseline recording of vagal nerve activity, electrocardiogram (ECG) and electrogastrogram (EGG) is then completed prior to beginning the vagal maneuvers.
Participants may be asked to perform any of the following maneuvers:
- Cough: Each subject will be asked to generate approximately 6 to 8 forceful and sustained coughs over 5 to 10 seconds.
- Cold stimulus to face: An ice pack or a washcloth soaked in ice water will be placed on each subject's face for about 10 seconds to mimic the physiological response of being submerged in cold water (Diver's Reflex)
- Carotid Massage: This technique is performed with the subject's neck in an extended position with the head turned away from the side being massaged. Only one side is massaged at a time. Pressure is applied underneath the angle of the jaw in a gentle circular motion for about 10 seconds. The subject is monitored throughout.
- Gagging: A tongue depressor is briefly inserted into the subject's mouth touching the back of the throat, which causes the person to reflexively gag.
- Valsalva maneuver: The subject is instructed to bear down as if they were having a bowel movement. The subject is asked to blow through a mouthpiece that is hooked to a device used in clinical spirometry until the pressure reaches 10mmHg.Alternatively, we can have the subject blow through the barrel of a 10 ml syringe for 15-20 seconds. This maneuver increases intrathoracic pressure and stimulates the vagus nerve.
After performing a maneuver for 10 seconds, another 8 minutes of recording will be made before doing any additional maneuvers.
Participants may also be asked to perform one or more eating maneuvers after an overnight fast.
- Eating: After 20 minutes of baseline recordings, subjects will be asked to drink 8 ounces of either water or Ensure Original. After the fluid is consumed, an additional 20 minutes of recordings will be made.
Maneuvers will be selected at the investigator's discretion and not all maneuvers will be completed. If both the water and Ensure eating maneuvers are selected, they will be completed at two separate visits.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis Subjects | Experimental | Other: Vagal ManeuversSubjects with a confirmed diagnosis of gastroparesis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
- Aged 18-80 years
- Willing to perform vagal activity maneuver (Vagal arm)
Key exclusion criteria (4 listed)
- Have an implanted gastric stimulator
- Unable to provide consent
- 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 |
|---|---|---|
| Vagal ManeuversSubjects will be asked to perform various maneuvers to stimulate the vagus nerve: * Cough: Produce 6 to 8 forceful coughs over 5 to 10 seconds * Cold stimulus to face: Have an ice cold washcloth placed on their face for 10 seconds. * Carotid massage: While the neck is extended and the head turned away from the side being massaged, pressure is applied underneath the angle of the jaw in a gentle circular motion for about 10 seconds. * Gagging: a tongue depressor is briefly inserted into the mouth touching the back of the throat. * Valsalva maneuver: subjects will will be asked to bear down as if they were having a bowel movement. They will be asked to blow through a mouthpiece that is hooked to a machine that measures how hard they are blowing. Alternatively, they can blow through the barrel of a 10 ml syringe for 15-20 seconds. * Eating: Subjects will be asked to drink 8 ounces of water and/or Ensure Original after fasting overnight | Other | Gastroparesis Subjects |
Primary outcome
Amplitude of vagal nerve compound action
Time frame: 3 hours
To measure the amplitude of vagal nerve compound action potentials during vagal maneuvers.
Respiratory Changes in heart rate during stimulation
Time frame: 3 hours
To measure respiratory changes in heart rate during vagal maneuvers.
Changes in amplitude of the surface electrogastrogram
Time frame: 3 hours
To measure the changes of surface electrogastogram during vagal maneuvers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with other researchers for similar purposes as to this study
Related trials for Gastroparesis
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Not yet recruiting
Effect Of Percutaneous Electrical Nerve Field Stimulation on Symptom Control/Nervous System Activity in Patients w/Diabetes Types 1/2
Diabetes, Gastroparesis
Recruiting
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Gastroparesis Nondiabetic
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
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal Maneuvers in people with Gastroparesis, 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 3 inclusion and 4 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 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amplitude of vagal nerve compound action (time frame: 3 hours). The study lists 3 primary outcomes in all. 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 19 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.