Mapping Auricular Vagus Nerve Circuitry

StatusRecruiting
PhaseEarly Phase 1
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv20
  2. Primary and study completion dates pushed to Jun 30, 2028v19 Show 6 more changesShow less
    • Start date: Feb 1, 2017 to Aug 22, 2023
    • Enrollment target: 60 to 50
    • Interventions: active auricular tVNS (Device), inactive auricular tVNS (Device) to active TEAS (Device)
    • Study description shortened, about 10 words
    • Study arms: 1 to 2
    • Eligibility criteria shortened, about 5 words
  3. Primary completion date: Jul 31, 2021 to Nov 30, 2022
    • Study completion date: Jul 2022 to Nov 2023
    • Site contact updated
    v18
  4. Primary completion date: Jul 31, 2020 to Jul 31, 2021
    • Study completion date: Jul 2021 to Jul 2022
    v17
  5. Primary completion date: May 2019 to Jul 31, 2020
    • Study completion date: May 2020 to Jul 2021
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary endpoints: 1 to 2
    • Secondary endpoints expanded, about 9 words
    • Study description expanded, about 16 words
    v15
  2. Interventions: active neuromodulation (Device), sham neuromodulation (Device) to active auricular tVNS (Device), inactive auricular tVNS (Device)
    • Site contact updated
    v14
  3. Primary completion date: Dec 2013 to May 2019v13 Show 8 more changesShow less
    • Start date: May 2005 to Feb 1, 2017
    • Trial status: Completed to Recruiting
    • Study completion date: Dec 2013 to May 2020
    • Interventions: Electro-acupuncture (Procedure), Manual acupuncture (Device), Sensory stimulation (Procedure), acupuncture (Device) to active neuromodulation (Device), sham neuromodulation (Device)
    • Study description shortened, about 59 words
    • Site details revised
    • Collaborator revised
    • Study title shortened, about 2 words
  4. Primary and study completion dates changed from estimate of May 2013 to Dec 2013v12 Show 4 more changesShow less
    • 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
    • Study arms: 0 to 1
  5. Primary and study completion dates: May 2009 to May 2013v11
  6. Re-verified, no change to tracked fieldsv10
  7. Lead sponsor: National Center for Complementary and Integrative Health (NCCIH) to Massachusetts General Hospital
    • Collaborators expanded, about 8 words
    v9
  8. Phase: Phase 1 to Early Phase 1v8
  9. Primary completion date: May 2009
    • Site contact updated
    v7
  10. Primary endpoint revised
    • Study description expanded, about 2 words
    v6
  11. Site contact updatedv5
  12. Re-verified, no change to tracked fieldsv4
  13. Phase: Not applicable to Phase 1
    • Study completion date: May 2009
    v3
  14. Primary endpoint revisedv2 Show 4 more changesShow less
    • Interventions: acupuncture (Procedure) to Electro-acupuncture (Procedure), Manual acupuncture (Procedure), Sensory stimulation (Procedure)
    • Study description shortened, about 113 words
    • Site contact updated
    • Eligibility criteria expanded, about 1 word
  1. Study First Submitted
  • 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
(from sponsor)		 Healthy
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov