GastroparesisABVN2NCT06491758
ABVN Phase 2 - Ear Stimulation
A study testing ML1101 Stimulus Isolator in people with Gastroparesis and Healthy Subjects, 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 hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis, Healthy Subjects
- What is being tested?
- ML1101 Stimulus Isolator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2020to 22 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers with no gastric symptoms or conditions (except due to COVID 19)
- Aged 18-80 years
- Willing to have electrodes placed in the external ear
- Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points
- Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
- Aged 18-80 years
- Willing to have electrodes placed in the external ear
- Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points
Who cannot join
- Unable to provide consent
- Pregnant females
- Prisoners
- Unable to provide consent
- Have an implanted gastric stimulator
- 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 (CNAPs) Phase 2 - Ear Stimulation
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function.
The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of transcutaneous electrical stimulation of the vagus nerve on vagal nerve CNAPs and gastric hormones in healthy subjects and in subjects with gastroparesis.
Read the detailed description
Both healthy volunteer subjects and patients with gastroparesis will be recruited for this project, which will be completed at a single study visit lasting up to 3 hours in duration.
When participants arrive, they will be fitted with:
- Two small disc electrodes placed in the auricle of the left ear, fixed by a plastic armature that wraps around the ear. The leads from the electrodes are connected to a stimulator. Electrical stimulation of the electrodes placed in the ear is provided by a current-constant stimulator. The stimuli consist of rectangular pulses with 450 µs pulse width, delivered at 30 Hz, and pulse train duration of 0.5 seconds. Stimulation is gated, and delivered only during the expiratory phase of respiration.
- A pneumatic belt will be placed around the lower thorax. Pneumatic tubes connect this belt to a pressure transducer that measures changes in chest diameter during breathing and sends signal to a laptop-controlled device.
- ECG electrodes are placed on:
- both sides of the neck overlying the right and left vagus nerves (to record vagal nerve activity)
- on the chest and arms or legs (for measurement of the electrocardiogram, or ECG)
- on the abdomen (to record the electrogastrogram, or EGG).
A butterfly catheter will be inserted under aseptic conditions into a peripheral vein, and a baseline blood sample will be collected. After the baseline blood sample collection, baseline vagal nerve, ECG and EGG recordings will be obtained for approximately 5-10 minutes. During the baseline recording, no current is delivered to the ear.
At the completion of the baseline recording, electrical stimulation will be sent to the ear electrodes at an intensity which should not cause pain. The current will be increased and decreased by 10 percent for 60 seconds until a comfortable level of sensation has been reached. Once the comfortable level of sensation has been identified (target level), the stimulation will be delivered for a total of 2 minutes. Twenty minutes after stopping the stimulation, another blood sample will be drawn. After an additional 20 minutes of rest, a final blood sample will be drawn. Continuous vagal nerve, ECG, and EGG recordings are obtained during all stimulation and rest periods.
- Conditions
- Gastroparesis, Healthy Subjects
- Being tested
- ML1101 Stimulus Isolator
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML1101 Stimulus IsolatorDevice
Electrical stimulation of the vagus nerve around the external ear using a transcutaneous device. Electrical current will be increased or decreased in intensity based on subject feedback. Once the target level has been achieved the stimulation will be delivered for 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | Subjects who have no gastric symptoms or conditions Receives: Device: ML1101 Stimulus Isolator |
| Gastroparesis Subjects | Experimental | Subjects with a confirmed diagnosis of gastroparesis. Receives: Device: ML1101 Stimulus Isolator |
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 transcutaneous stimulation of the auricular branch of the vagal nerve.
Measured: 3 hours
Respiratory Changes in heart rate during stimulation
To measure respiratory changes in heart rate during transcutaneous stimulation of the auricular branch of the vagal nerve.
Measured: 3 hours
Changes in amplitude of the surface electrogastrogram
To measure the changes of surface electrogastogram during transcutaneous stimulation of the auricular branch of the vagal nerve.
Measured: 3 hours
Changes in gastric hormones
To measure the effect of transcutaneous stimulation of the auricular branch of the vagal nerve on gastric hormones.
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 posted9 Jul 2024
- Study start5 Nov 2020
- Primary completion22 Mar 2022
- Study completion22 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT06491758
- Sponsor's protocol ID
- 2006075899-A
- Other IDs
- 1OT2OD028183-01
- Acronym
- ABVN2
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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 16 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 (CNAPs) Phase 2 - Ear Stimulation
- ClinicalTrials.gov ID
- NCT06491758
- Acronym / sponsor ID
- ABVN2 / 2006075899-A
- Conditions
- Gastroparesis, Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University, National Institutes of Health (NIH)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 22 Mar 2022 (actual)
- First posted
- 9 Jul 2024 (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 hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function.
The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of transcutaneous electrical stimulation of the vagus nerve on vagal nerve CNAPs and gastric hormones in healthy subjects and in subjects with gastroparesis.
Detailed description
Both healthy volunteer subjects and patients with gastroparesis will be recruited for this project, which will be completed at a single study visit lasting up to 3 hours in duration.
When participants arrive, they will be fitted with:
- Two small disc electrodes placed in the auricle of the left ear, fixed by a plastic armature that wraps around the ear. The leads from the electrodes are connected to a stimulator. Electrical stimulation of the electrodes placed in the ear is provided by a current-constant stimulator. The stimuli consist of rectangular pulses with 450 µs pulse width, delivered at 30 Hz, and pulse train duration of 0.5 seconds. Stimulation is gated, and delivered only during the expiratory phase of respiration.
- A pneumatic belt will be placed around the lower thorax. Pneumatic tubes connect this belt to a pressure transducer that measures changes in chest diameter during breathing and sends signal to a laptop-controlled device.
- ECG electrodes are placed on:
- both sides of the neck overlying the right and left vagus nerves (to record vagal nerve activity)
- on the chest and arms or legs (for measurement of the electrocardiogram, or ECG)
- on the abdomen (to record the electrogastrogram, or EGG).
A butterfly catheter will be inserted under aseptic conditions into a peripheral vein, and a baseline blood sample will be collected. After the baseline blood sample collection, baseline vagal nerve, ECG and EGG recordings will be obtained for approximately 5-10 minutes. During the baseline recording, no current is delivered to the ear.
At the completion of the baseline recording, electrical stimulation will be sent to the ear electrodes at an intensity which should not cause pain. The current will be increased and decreased by 10 percent for 60 seconds until a comfortable level of sensation has been reached. Once the comfortable level of sensation has been identified (target level), the stimulation will be delivered for a total of 2 minutes. Twenty minutes after stopping the stimulation, another blood sample will be drawn. After an additional 20 minutes of rest, a final blood sample will be drawn. Continuous vagal nerve, ECG, and EGG recordings are obtained during all stimulation and rest periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Device: ML1101 Stimulus IsolatorSubjects who have no gastric symptoms or conditions |
| Gastroparesis Subjects | Experimental | Device: ML1101 Stimulus IsolatorSubjects with a confirmed diagnosis of gastroparesis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy volunteers with no gastric symptoms or conditions (except due to COVID 19)
- Aged 18-80 years
- Willing to have electrodes placed in the external ear
- Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points
- Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
Key exclusion criteria (7 listed)
- Unable to provide consent
- Pregnant females
- Prisoners
- Unable to provide consent
- Have an implanted gastric stimulator
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 |
|---|---|---|
| ML1101 Stimulus IsolatorElectrical stimulation of the vagus nerve around the external ear using a transcutaneous device. Electrical current will be increased or decreased in intensity based on subject feedback. Once the target level has been achieved the stimulation will be delivered for 2 minutes. | Device | Gastroparesis Subjects, Healthy Subjects |
Primary outcome
Amplitude of vagal nerve compound action
Time frame: 3 hours
To measure the amplitude of vagal nerve compound action potentials during transcutaneous stimulation of the auricular branch of the vagal nerve.
Respiratory Changes in heart rate during stimulation
Time frame: 3 hours
To measure respiratory changes in heart rate during transcutaneous stimulation of the auricular branch of the vagal nerve.
Changes in amplitude of the surface electrogastrogram
Time frame: 3 hours
To measure the changes of surface electrogastogram during transcutaneous stimulation of the auricular branch of the vagal nerve.
Changes in gastric hormones
Time frame: 3 hours
To measure the effect of transcutaneous stimulation of the auricular branch of the vagal nerve on gastric hormones.
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 16 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
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
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
Recruiting
Effect of Gastric Electrical Stimulation on Serum Insulin Levels
Gastroparesis Nondiabetic
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
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 ML1101 Stimulus Isolator in people with Gastroparesis and Healthy Subjects, 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 8 inclusion and 7 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 16 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 4 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 16 Oct 2026.