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 : May 28, 2018
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital

September 13, 2005
September 20, 2005
May 28, 2018
February 1, 2017
May 2019   (Final data collection date for primary outcome measure)
Brain activity during functional magnetic resonance imaging (fMRI) [ Time Frame: 1 hour ]
Assess the brain response to neuromodulation by comparing the imaging data during active stimulation with that of sham stimulation
Brain activity; measured via fMRI throughout the study
Complete list of historical versions of study NCT00200889 on Archive Site
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Mapping Auricular Vagus Nerve Circuitry
Spatiotemporal Patterns for Neuromodulation Processing in the Brain Using MRI and M/EEG
This study will determine how vagus nerve stimulation affects human brain and autonomic activity.

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 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 and physiological monitoring.

This study will comprise 1-2 functional magnetic resonance imaging (fMRI) brain scans while receiving the neuromodulation with varying parameters. Participants will also have their heart rate and breathing monitored during the brain scans.

Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Device: active neuromodulation
    non-painful stimulation will be delivered to the left ear
  • Device: sham neuromodulation
    A sham stimulation will be used at the ear
Experimental: neuromodulation
active neuromodulation or sham neuromodulation will be applied
  • Device: active neuromodulation
  • Device: sham neuromodulation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2020
May 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Right-handed

Exclusion Criteria:

  • Any condition contraindicating an fMRI brain scan
  • Any neurological or psychiatric disorders
  • Any pain syndromes
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact: Vitaly Napadow, PhD; Lic.Ac. 617 286 6670
United States
1OT2OD023867-01 ( U.S. NIH Grant/Contract )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital
Massachusetts General Hospital
National Institutes of Health (NIH)
Principal Investigator: Vitaly Napadow, PhD Harvard University
Massachusetts General Hospital
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP