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NCT Number: NCT00200889

Mapping Auricular Vagus Nerve Circuitry

This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Andy Bolender

CONTACT

[email protected]

Vitaly Napadow, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18-65
  • Functional dyspepsia

Exclusion criteria

  • Any condition contraindicating an fMRI brain scan

Treatment and study plan

active TEAS

Device

non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg

Primary outcomes

  1. 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

  2. Stomach activity during gastric magnetic resonance imaging (MRI)

    Time frame: 30 minutes

    Gastric accommodation and sensitivity change between active and inactive auricular tVNS

Secondary outcomes

  1. Electrogastrography (EGG)

    Time frame: 2 hours

    We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.

  2. Electrocardiography (ECG)

    Time frame: 2 hours

    We will use ECG to examine high frequency heart rate variability (HF-HRV), i.e. the R-peak of the QRS complex.

  3. Respiration

    Time frame: 2 hours

    Respiration will be measured in beats per minute (bpm).

  4. Skin Conductance Levels (SCL)

    Time frame: 2 hours

    SCL will be measured in volts per second.

Study contacts

Contact information is provided by the study sponsor or research team.

Andy Bolender, B.A.

CONTACT

[email protected]

617-643-4297

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 20, 2005
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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