GastroparesisAVNSNCT05405842
Transauricular Vagal Nerve Stimulation; Functional Dyspepsia and Gastroparesis
A study testing Transauricular Vagal Nerve Stimulation in people with Gastroparesis and Functional Dyspepsia, run by Stanford University.
Trial summary
The goal of this study is to establish parameters of gastric myoelectrical activity and heart rate variability in healthy human subjects and compare and contrast them to those with gastroparesis and functional dyspepsia, at baseline and following taVNS. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis, Functional Dyspepsia, Healthy
- What is being tested?
- Transauricular Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Sep 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female.
- Age 18-85 years.
- Healthy volunteer or established diagnosis of idiopathic, diabetic, or postsurgical gastroparesis and functional dyspepsia.
- Patient is capable of giving informed consent.
- Patient is on stable doses of other medications for gastroparesis or functional dyspepsia for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).
Who cannot join
- Any diagnosis of systemic autonomic dysfunction.
- Use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study.
- Enteric feeding tubes.
- Parenteral nutrition.
- Severe disease flare requiring hospitalization or ER visits within 3 months of study.
- Untreated depression or suicidal thoughts.
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- Pregnant/breastfeeding women.
- History of gastric pacemaker implantation.
- Implantable electronic devices (i.e. cardiac pacemakers)
- Extrinsic myopathy/neuropathy
- Vagal nerve injury.
- High risk cardiac arrhythmias (high grade AV block, atrial fibrillation, atrial flutter).
- GERD.
- History of dumping syndrome.
- History of rapid gastric emptying.
- Severe allergy to skin adhesives.
- Concurrent enrollment in other clinical trials.
About this study
Official title: Effects of Transauricular Vagal Nerve Stimulation on Electrogastrography (EGG) and Heart Rate Variability (HRV) in Healthy Subjects, Functional Dyspepsia, and Gastroparesis
The goal of this study is to establish parameters of gastric myoelectrical activity and heart rate variability in healthy human subjects and compare and contrast them to those with gastroparesis and functional dyspepsia, at baseline and following taVNS.
Read the detailed description
This is a prospective pilot study assessing the relationship of electrogastrography and heart rate variability, with transauricular stimulation of the vagal nerve in healthy subjects compared to gastroparesis and functional dyspepsia patients. The investigators plan to recruit a total of 60 patients: 20 healthy volunteers, 20 gastroparesis, and 20 functional dyspepsia patients. Participants will undergo two testing sessions in which electrogastrography (EGG) and heart rate variability (HRV) will be measured using electrodes following transauricular vagal nerve stimulation (tAVNS) at various frequencies.
- Being tested
- Transauricular Vagal Nerve Stimulation
- Keywords
- vagal nerve stimulation, EGG, gastroparesis, functional dyspepsia, auricular, stanford, digestive, gastroenterology
- Medical subject headings
- Gastroparesis, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transauricular Vagal Nerve StimulationDevice
Also called vagal nerve stimulation
TENS 7000 is a handheld device used to deliver electrical impulses for nerve stimulation to help modulate and treat chronic pain. The manufacturer, Roscoe, has regulatory approval for the use of nerve stimulator therapy in the acute and/or prophylactic treatment of headaches, migraines, sciatica, muscle spasms, acute and chronic pain, and improve circulation. It is FDA approved in the USA for the above indications, but has not been approved for use in gastrointestinal diseases such as gastroparesis or functional dyspepsia. It has been registered as an investigational new device in various clinical trials. The purpose of this protocol is to provide vagal nerve stimulation to patients with gastroparesis, functional dyspepsia, and healthy controls as a comparison.
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis | Experimental | Patients diagnosed with Gastroparesis. Receives: Device: Transauricular Vagal Nerve Stimulation |
| Functional Dsypepsia | Experimental | Patients diagnosed with Functional Dsypepsia. Receives: Device: Transauricular Vagal Nerve Stimulation |
| Healthy Controls | Experimental | Healthy volunteers (without Functional Dsypepsia or Gastroparesis) Receives: Device: Transauricular Vagal Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish EGG/HRV parameters and effects following taVNS
The first primary outcome measure will be to establish measures of EGG and HRV parameters in healthy volunteers and determine effects of tAVNS on EGG and HRV. The HRV parameters to be measured will include mean heart rate (HR), standard deviation of HR, mean respiratory rate (RR) interval, standard deviation of RR interval, low/high frequency (LF, HF, LF/HF), normalized LF, and normalized HF. The EGG parameters to be measured will be of gastric slow wave power, gastric slow wave propagation, and phase gradient directionality.
Measured: 3-5 years
Secondary outcomes (1)
Determine deviations in EGG/HRV parameters and effects following taVNS
To determine if gastroparesis or functional dyspepsia patients have significant deviations in EGG (slow wave power, propagation, and phase gradient directionality) and HRV (mean HR, LF, HF, mean RR) parameters at baseline and following tAVNS compared to healthy volunteers.
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: There were equipment issues with the vendor that could not be resolved; therefore, enrollment was never opened.
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- n= 60 3 groups : gastroparesis (n=20); functional dyspepsia (n=20) ; health controls (n=20)
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Nguyen, Stanford University
- Investigators
- Wendy XY Zhou, DO, Study director, FellowSandya Subramanian, Phd, Principal investigator, Postdoctoral FellowTodd Coleman, Phd, Principal investigator, Associate ProfessorLinda Nguyen, MD, Principal investigator, Clinical Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405842
- Sponsor's protocol ID
- 63421
- Acronym
- AVNS
- Status last verified
- Jul 2025
- First submitted
- 23 May 2022
- Last updated
- 3 Aug 2025
- Results posted
- No
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transauricular Vagal Nerve Stimulation on Electrogastrography (EGG) and Heart Rate Variability (HRV) in Healthy Subjects, Functional Dyspepsia, and Gastroparesis
- ClinicalTrials.gov ID
- NCT05405842
- Acronym / sponsor ID
- AVNS / 63421
- Keywords
- vagal nerve stimulation, EGG, gastroparesis, functional dyspepsia, auricular, stanford, digestive, gastroenterology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There were equipment issues with the vendor that could not be resolved; therefore, enrollment was never opened.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 6 Jun 2022 (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 goal of this study is to establish parameters of gastric myoelectrical activity and heart rate variability in healthy human subjects and compare and contrast them to those with gastroparesis and functional dyspepsia, at baseline and following taVNS.
Detailed description
This is a prospective pilot study assessing the relationship of electrogastrography and heart rate variability, with transauricular stimulation of the vagal nerve in healthy subjects compared to gastroparesis and functional dyspepsia patients. The investigators plan to recruit a total of 60 patients: 20 healthy volunteers, 20 gastroparesis, and 20 functional dyspepsia patients. Participants will undergo two testing sessions in which electrogastrography (EGG) and heart rate variability (HRV) will be measured using electrodes following transauricular vagal nerve stimulation (tAVNS) at various frequencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- n= 60 3 groups : gastroparesis (n=20); functional dyspepsia (n=20) ; health controls (n=20)
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis | Experimental | Device: Transauricular Vagal Nerve StimulationPatients diagnosed with Gastroparesis. |
| Functional Dsypepsia | Experimental | Device: Transauricular Vagal Nerve StimulationPatients diagnosed with Functional Dsypepsia. |
| Healthy Controls | Experimental | Device: Transauricular Vagal Nerve StimulationHealthy volunteers (without Functional Dsypepsia or Gastroparesis) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female.
- Age 18-85 years.
- Healthy volunteer or established diagnosis of idiopathic, diabetic, or postsurgical gastroparesis and functional dyspepsia.
- Patient is capable of giving informed consent.
- Patient is on stable doses of other medications for gastroparesis or functional dyspepsia for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).
Key exclusion criteria (17 listed)
- Any diagnosis of systemic autonomic dysfunction.
- Use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study.
- Enteric feeding tubes.
- Parenteral nutrition.
- Severe disease flare requiring hospitalization or ER visits within 3 months of study.
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 |
|---|---|---|
| Transauricular Vagal Nerve StimulationAlso: vagal nerve stimulationTENS 7000 is a handheld device used to deliver electrical impulses for nerve stimulation to help modulate and treat chronic pain. The manufacturer, Roscoe, has regulatory approval for the use of nerve stimulator therapy in the acute and/or prophylactic treatment of headaches, migraines, sciatica, muscle spasms, acute and chronic pain, and improve circulation. It is FDA approved in the USA for the above indications, but has not been approved for use in gastrointestinal diseases such as gastroparesis or functional dyspepsia. It has been registered as an investigational new device in various clinical trials. The purpose of this protocol is to provide vagal nerve stimulation to patients with gastroparesis, functional dyspepsia, and healthy controls as a comparison. | Device | Functional Dsypepsia, Gastroparesis, Healthy Controls |
Primary outcome
Establish EGG/HRV parameters and effects following taVNS
Time frame: 3-5 years
The first primary outcome measure will be to establish measures of EGG and HRV parameters in healthy volunteers and determine effects of tAVNS on EGG and HRV. The HRV parameters to be measured will include mean heart rate (HR), standard deviation of HR, mean respiratory rate (RR) interval, standard deviation of RR interval, low/high frequency (LF, HF, LF/HF), normalized LF, and normalized HF. The EGG parameters to be measured will be of gastric slow wave power, gastric slow wave propagation, and phase gradient directionality.
1 secondary outcome
Determine deviations in EGG/HRV parameters and effects following taVNS
Time frame: 3-5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- 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.
Wendy XY Zhou, DO study director
Fellow
Sandya Subramanian, Phd principal investigator
Postdoctoral Fellow
Todd Coleman, Phd principal investigator
Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing Transauricular Vagal Nerve Stimulation in people with Gastroparesis and Functional Dyspepsia, run by Stanford University.
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 5 inclusion and 17 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: withdrawn, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Establish EGG/HRV parameters and effects following taVNS (time frame: 3-5 years). 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 3 Aug 2025.