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Mapping Auricular Vagus Nerve Circuitry

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ClinicalTrials.gov Identifier: NCT00200889
Recruitment Status : Recruiting
First Posted : September 20, 2005
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2018)
  • 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
  • Stomach activity during gastric magnetic resonance imaging (MRI) [ Time Frame: 30 minutes ]
    Gastric accommodation and sensitivity change between active and inactive auricular tVNS
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
Brain activity; measured via fMRI throughout the study
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2018)
  • Electrogastrography (EGG) [ Time Frame: 2 hours ]
    We will use EGG to measure slow wave myoelectrical activity, as measured by EGG power/peak frequency.
  • 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.
  • Respiration [ Time Frame: 2 hours ]
    Respiration will be measured in beats per minute (bpm).
  • Skin Conductance Levels (SCL) [ Time Frame: 2 hours ]
    SCL will be measured in volts per second.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mapping Auricular Vagus Nerve Circuitry
Official Title  ICMJE Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes
Brief Summary This study will determine how vagus nerve stimulation affects human brain, stomach, and autonomic activity.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: auricular tVNS
active and inactive auricular transcutaneous vagus nerve stimulation (tVNS)
Interventions:
  • Device: active auricular tVNS
  • Device: inactive auricular tVNS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2005)
60
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Right-handed

Exclusion Criteria:

  • Any condition contraindicating an fMRI brain scan
  • Any neurological or psychiatric disorders
  • Any pain syndromes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rowan Staley, B.A. 617-643-9790 rstaley@mgh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200889
Other Study ID Numbers  ICMJE 2009P002177
3OT2OD023867-01S2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Vitaly Napadow, PhD Harvard University
PRS Account Massachusetts General Hospital
Verification Date April 2020

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