HealthyEarly Phase 1NCT00200889
Mapping Auricular Vagus Nerve Circuitry
A Early Phase 1 study testing active TEAS in people with Healthy, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- active TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2023to 30 Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18-65
- Functional dyspepsia
Who cannot join
- Any condition contraindicating an fMRI brain scan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Andy Bolender, abolender@mgh.harvard.edu
Vitaly Napadow, PhD
About this study
Official title: Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes
This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.
Read the detailed description
Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous electro-accupoint stimulation, which is non-invasive and non-painful, affects human brain, stomach, and autonomic activity. We will accomplish this by integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring.
This study will comprise 3 functional magnetic resonance imaging (fMRI) brain-gut scans, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.
- Conditions
- Healthy
- Being tested
- active TEAS
- Keywords
- Acupuncture, Magnetic Resonance Imaging, Functional, Brain Mapping, healthy volunteers, Neuromodulation, gastric MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active TEASDevice
non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg
| Study group | Role | What they receive |
|---|---|---|
| Congruent | Experimental | Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature. Receives: Device: active TEAS |
| Incongruent | Experimental | Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature. Receives: Device: active TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activity during functional magnetic resonance imaging (fMRI)
Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS
Measured: 1 hour
Stomach activity during gastric magnetic resonance imaging (MRI)
Gastric accommodation and sensitivity change between active and inactive auricular tVNS
Measured: 30 minutes
Secondary outcomes (4)
Electrogastrography (EGG)
We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.
Measured: 2 hours
Electrocardiography (ECG)
We will use ECG to examine high frequency heart rate variability (HF-HRV), i.e. the R-peak of the QRS complex.
Measured: 2 hours
Respiration
Respiration will be measured in beats per minute (bpm).
Measured: 2 hours
Skin Conductance Levels (SCL)
SCL will be measured in volts per second.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study start22 Aug 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to "Congruent" or "Incongruent" briefing groups. The Congruent group receives briefings including expectations of stimulation effects on gastric motility consistent with prior research in the literature. The Incongruent group receives briefings including expectations of stimulation effects on gastric motility inconsistent with prior research in the literature.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital
- Investigators
- Vitaly Napadow, PhD, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200889
- Sponsor's protocol ID
- 2009P002177
- Other IDs
- 3OT2OD023867-01S2
- Status last verified
- Oct 2025
- First submitted
- 13 Sep 2005
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes
- ClinicalTrials.gov ID
- NCT00200889
- Acronym / sponsor ID
- 2009P002177
- Conditions
- Healthy
- Keywords
- Acupuncture, Magnetic Resonance Imaging, Functional, Brain Mapping, healthy volunteers, Neuromodulation, gastric MRI
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- 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.
This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.
Detailed description
Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous electro-accupoint stimulation, which is non-invasive and non-painful, affects human brain, stomach, and autonomic activity. We will accomplish this by integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring.
This study will comprise 3 functional magnetic resonance imaging (fMRI) brain-gut scans, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to "Congruent" or "Incongruent" briefing groups. The Congruent group receives briefings including expectations of stimulation effects on gastric motility consistent with prior research in the literature. The Incongruent group receives briefings including expectations of stimulation effects on gastric motility inconsistent with prior research in the literature.
| Arm | Type | Receives |
|---|---|---|
| Congruent | Experimental | Device: active TEASParticipants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature. |
| Incongruent | Experimental | Device: active TEASParticipants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18-65
- Functional dyspepsia
Key exclusion criteria (1 listed)
- Any condition contraindicating an fMRI brain scan
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 |
|---|---|---|
| active TEASnon-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg | Device | Congruent, Incongruent |
Primary outcome
Brain activity during functional magnetic resonance imaging (fMRI)
Time frame: 1 hour
Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS
Stomach activity during gastric magnetic resonance imaging (MRI)
Time frame: 30 minutes
Gastric accommodation and sensitivity change between active and inactive auricular tVNS
4 secondary outcomes
Electrogastrography (EGG)
Time frame: 2 hours
Electrocardiography (ECG)
Time frame: 2 hours
Respiration
Time frame: 2 hours
Skin Conductance Levels (SCL)
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
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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.
Vitaly Napadow, PhD principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing active TEAS in people with Healthy, run by Massachusetts General Hospital 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Oct 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andy Bolender, B.A. (617-643-4297, abolender@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity during functional magnetic resonance imaging (fMRI) (time frame: 1 hour). The study lists 2 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 24 Oct 2025.