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Mapping Auricular Vagus Nerve Circuitry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00200889
Recruitment Status : Recruiting
First Posted : September 20, 2005
Last Update Posted : April 24, 2020
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital

Brief Summary:
This study will determine how vagus nerve stimulation affects human brain, stomach, and autonomic activity.

Condition or disease Intervention/treatment Phase
Healthy Device: active auricular tVNS Device: inactive auricular tVNS Early Phase 1

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 vagus nerve stimulation, which is non-invasive and non-painful, affects human brain 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 2 functional magnetic resonance imaging (fMRI) brain-gut scans and 2 behavioral visits consisting of a nutrient drink test, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: auricular tVNS
active and inactive auricular transcutaneous vagus nerve stimulation (tVNS)
Device: active auricular tVNS
non-painful active auricular tVNS will be delivered to the left ear

Device: inactive auricular tVNS
non-painful inactive auricular tVNS will be delivered to the left ear

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Right-handed

Exclusion Criteria:

  • Any condition contraindicating an fMRI brain scan
  • Any neurological or psychiatric disorders
  • Any pain syndromes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200889

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Contact: Rowan Staley, B.A. 617-643-9790

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Harrison Fisher   
Principal Investigator: Vitaly Napadow, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
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Principal Investigator: Vitaly Napadow, PhD Harvard University
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Responsible Party: Vitaly Napadow, Ph.D., Lic.Ac., Assistant Professor, Massachusetts General Hospital Identifier: NCT00200889    
Other Study ID Numbers: 2009P002177
3OT2OD023867-01S2 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital:
Magnetic Resonance Imaging, Functional
Brain Mapping
healthy volunteers
gastric MRI