Mapping Auricular Vagus Nerve Circuitry

April 22, 2024 updated by: Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital

Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Vitaly Napadow, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults 18-65
  • Functional dyspepsia

Exclusion Criteria:

  • Any condition contraindicating an fMRI brain scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Congruent
Participants receive briefings on expectations of stimulation effects on gastric motility consistent with the literature.
Device: active TEAS
non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg
Experimental: Incongruent
Participants receive briefings on expectations of stimulation effects on gastric motility inconsistent with the literature.
Device: active TEAS
non-painful active transcutaneous electro-acupoint stimulation will be delivered to the abdomen and leg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour
Stomach activity during gastric magnetic resonance imaging (MRI)
Time Frame: 30 minutes
Gastric accommodation and sensitivity change between active and inactive auricular tVNS
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrogastrography (EGG)
Time Frame: 2 hours
We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.
2 hours
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.
2 hours
Respiration
Time Frame: 2 hours
Respiration will be measured in beats per minute (bpm).
2 hours
Skin Conductance Levels (SCL)
Time Frame: 2 hours
SCL will be measured in volts per second.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Vitaly Napadow, PhD, Harvard University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2023

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimated)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2009P002177
  • 3OT2OD023867-01S2 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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