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Mapping Auricular Vagus Nerve Circuitry

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v20

  2. Notable

    Primary completion date: Nov 30, 2022 to Jun 30, 2028

    Start date: Feb 1, 2017 to Aug 22, 2023; Enrollment target: 60 to 50; Completion date: Nov 2023 to Jun 30, 2028; and 4 more

    Show all 8 changes in this update
    • Notable Primary completion date: Nov 30, 2022 to Jun 30, 2028
    • Notable Start date: Feb 1, 2017 to Aug 22, 2023
    • Minor Enrollment target: 60 to 50
    • Minor Completion date: Nov 2023 to Jun 30, 2028
    • Minor Interventions: active auricular tVNS (Device), inactive auricular tVNS (Device) to active TEAS (Device)
    • Minor Eligibility criteria shortened, about 5 words
      Show what changed
      Inclusion Criteria: RightAdults 18-handed65 Functional dyspepsia Exclusion Criteria: Any condition contraindicating an fMRI brain scan Any neurological or psychiatric disorders Any pain syndromes
    • Minor Study description shortened, about 10 words
      Show what changed
      [...] to determine how a form of neuromodulation, transcutaneous vagus nerveelectro-accupoint stimulation, which is non-invasive and non-painful, affects human brain, stomach, and autonomic activity. We will accomplish this by integrat [...] MRI and physiological monitoring. This study will comprise 23 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 param [...]
    • Minor Study arms: 1 to 2

    Study Status, Study Description, Study Design, Arms and Interventions, Eligibilityv19

  3. Notable

    Primary completion date: Jul 31, 2021 to Nov 30, 2022

    Completion date: Jul 2022 to Nov 2023; Site contact updated

    Study Status, Contacts/Locationsv18

  4. Notable

    Primary completion date: Jul 31, 2020 to Jul 31, 2021

    Completion date: Jul 2021 to Jul 2022

    Study Statusv17

  5. Notable

    Primary completion date: May 2019 to Jul 31, 2020

    Completion date: May 2020 to Jul 2021

    Study Statusv16

Show 14 earlier versions

  1. Notable

    Primary endpoints: 1 to 2

    Secondary endpoints expanded, about 9 words; Study description expanded, about 16 words

    Show what changed: Primary endpoints
    Stomach activity during gastric magnetic resonance imaging (MRI)
    Show what changed: Secondary endpoints
    Electrogastrography (EGG) Electrocardiography (ECG) Respiration Skin Conductance Levels (SCL)
    Show what changed: Study description
    [...] The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous vagus nerve stimulation, wh [...] integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring. This study will comprise 1-2 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 breathinggastric activity monitored during theall brain scansvisits.

    Study Identification, Study Status, Study Description, Conditions, Outcome Measures, Contacts/Locationsv15

  2. Minor

    Interventions: active neuromodulation (Device), sham neuromodulation (Device) to active auricular tVNS (Device), inactive auricular tVNS (Device)

    Site contact updated

    Study Status, Arms and Interventions, Outcome Measures, Contacts/Locationsv14

  3. Notable

    Primary completion date: Dec 2013 to May 2019

    Start date: May 2005 to Feb 1, 2017; Trial status: Completed to Recruiting; Completion date: Dec 2013 to May 2020; and 5 more

    Show all 9 changes in this update
    • Notable Primary completion date: Dec 2013 to May 2019
    • Notable Start date: May 2005 to Feb 1, 2017
    • Minor Trial status: Completed to Recruiting
    • Minor Completion date: Dec 2013 to May 2020
    • Minor Interventions: Electro-acupuncture (Procedure), Manual acupuncture (Device), Sensory stimulation (Procedure), acupuncture (Device) to active neuromodulation (Device), sham neuromodulation (Device)
    • Minor Study description shortened, about 59 words
      Show what changed
      AcupunctureScientific research into the basic mechanisms underlying neuromodulation is anrelatively ancientrecent Chineseand practiceincomplete. The involving the insertion of needles into specific partspurpose of the body for therapeutic purposes. Although the practice has become more popular in the West, the underlying mechanisms of acupuncture have not been thoroughly examined. Thisproposed study willis to determine how acupuncturea form neuromodulation, transcutaneous vagus nerve stimulation, which is non-invasive and non-painful, affects human brain and autonomic activity,. We particularl [...] [...]
    • Minor Site details revised
    • Minor Collaborator revised
      Show what changed
      National CenterInstitutes for Complementary and Integrativeof Health (NCCIHNIH)
    • Minor Study title shortened, about 2 words
      Show what changed
      EffectMapping ofAuricular AcupunctureVagus onNerve Human Brain ActivityCircuitry

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv13

  4. Notable

    Primary and study completion dates changed from estimate of May 2013 to Dec 2013

    Trial status: Recruiting to Completed; Interventions: Electro-acupuncture (Procedure), Manual acupuncture (Procedure), Sensory stimulation (Procedure) to Electro-acupuncture (Procedure), Manual acupuncture (Device), Sensory stimulation (Procedure), acupuncture (Device); Site details revised; and 1 more

    Show all 5 changes in this update
    • Notable Primary and study completion dates changed from estimate of May 2013 to Dec 2013
    • Minor Trial status: Recruiting to Completed
    • Minor Interventions: Electro-acupuncture (Procedure), Manual acupuncture (Procedure), Sensory stimulation (Procedure) to Electro-acupuncture (Procedure), Manual acupuncture (Device), Sensory stimulation (Procedure), acupuncture (Device)
    • Minor Site details revised
    • Minor Study arms: 0 to 1

    Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Contacts/Locationsv12

  5. Notable

    Primary and study completion dates: May 2009 to May 2013

    Study Statusv11

  6. Minor

    Study Status

    Re-verified, no change to tracked fields

    v10

  7. Notable

    Lead sponsor: National Center for Complementary and Integrative Health (NCCIH) to Massachusetts General Hospital

    Collaborators expanded, about 8 words

    Show what changed: Collaborators
    National Center for Complementary and Integrative Health (NCCIH)

    Study Identification, Study Status, Sponsor/Collaboratorsv9

  8. Notable

    Phase: Phase 1 to Early Phase 1

    Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv8

  9. Minor

    Primary completion date: May 2009

    Site contact updated

    Study Status, Sponsor/Collaborators, Contacts/Locationsv7

  10. Notable

    Primary endpoint revised

    Study description expanded, about 2 words

    Show what changed: Primary endpoints
    Brain activity during functional magnetic resonance imaging (fMRI)
    Show what changed: Study description
    [...] ceive manual acupuncture; electro-acupuncture, which passes an electrical current through the needles; or some type of sensory stimulation. At Visit 2, p [...]

    Study Status, Study Description, Conditions, Study Design, Outcome Measuresv6

  11. Minor

    Site contact updated

    Study Status, Contacts/Locationsv5

  12. Minor

    Study Status

    Re-verified, no change to tracked fields

    v4

  13. Notable

    Phase: Not applicable to Phase 1

    Completion date: May 2009

    Study Status, Conditions, Study Designv3

  14. Notable

    Primary endpoint revised

    Interventions: acupuncture (Procedure) to Electro-acupuncture (Procedure), Manual acupuncture (Procedure), Sensory stimulation (Procedure); Eligibility criteria expanded, about 1 word; Study description shortened, about 113 words; and 1 more

    Show all 5 changes in this update
    • Notable Primary endpoint revised
      Show what changed
      Brain activity; measured viaduring fMRI throughout the study
    • Minor Interventions: acupuncture (Procedure) to Electro-acupuncture (Procedure), Manual acupuncture (Procedure), Sensory stimulation (Procedure)
    • Minor Eligibility criteria expanded, about 1 word
      Show what changed
      Inclusion Criteria: Right-handed Exclusion Criteria: InformedAny thatcondition havingcontraindicating an MRIfMRI isbrain medicallyscan Any inadvisable Neurologicalneurological or psychiatric disorders PainAny pain syndromes
    • Minor Study description shortened, about 113 words
      Show what changed
      Acupuncture is an ancient (overChinese 2500practice yearsinvolving old)the insertion of needles into specific parts of the body for therapeutic purposes. Although the practice thathas originatedbecome inmore China and is growing in popularitypopular in the West. However, scientific research into the basicunderlying mechanisms underlyingof acupuncture ishave relativelynot recentbeen andthoroughly incompleteexamined. The purpose of the proposedThis study is towill determine how acupuncture, with its variable treatment locations and stimulation techniques, affects human brain activity. We will ac [...] [...]
    • Minor Site contact updated

    Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.
Trial Details
NCT Number NCT00200889
Lead Sponsor Massachusetts General Hospital
Collaborators: National Institutes of Health (NIH)
Conditions Healthy
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov