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

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

Condition or disease Intervention/treatment Phase
Healthy Device: active neuromodulation Device: sham neuromodulation 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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Spatiotemporal Patterns for Neuromodulation Processing in the Brain Using MRI and M/EEG
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: neuromodulation
active neuromodulation or sham neuromodulation will be applied
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Contact: Vitaly Napadow, PhD; Lic.Ac. 617 286 6670

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Vitaly Napadow   
Principal Investigator: Vitaly Napadow, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Principal Investigator: Vitaly Napadow, PhD Harvard University

Responsible Party: Vitaly Napadow, Ph.D., Lic.Ac., Assistant Professor, Massachusetts General Hospital Identifier: NCT00200889     History of Changes
Other Study ID Numbers: 2005P000466
1OT2OD023867-01 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018

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