ABVN Phase 1 - Ear Stimulation

Study acronym: ABVN1
StatusCompleted
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified Show 9 more changesShow less
    • Trial completed
    • Final enrollment: 23 participants (planned 30)
    • Primary completion date changed from estimate of Aug 31, 2026 to Jan 29, 2020
    • Interventions modified
    • Secondary endpoints shortened, about 7 words
    • Study description shortened, about 644 words
    • Collaborators: 1 to 2
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 1 word
  2. Notable Primary completion date: Aug 31, 2025 to Aug 31, 2026
    • Study completion date: Aug 31, 2026 to Aug 31, 2027
    v7
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  4. Minor Interventions: Transcutaneous Auricular Vagus Nerve Stimulation (Device), Vagal Maneuvers (Other) to Transcutaneous Auricular Vagus Nerve Stimulation (Device), Vagal Stimulation (Procedure)v5
  5. Minor 2 versions Re-verified since Feb 6, 2024, no change to tracked fieldsv3-v4
  6. Notable Primary completion date: Aug 31, 2022 to Aug 31, 2025v2 Show 4 more changesShow less
    • Study completion date: Aug 31, 2025 to Aug 31, 2026
    • Interventions: ABVN stimulation (Other), Vagal Maneuvers (Other) to Transcutaneous Auricular Vagus Nerve Stimulation (Device), Vagal Maneuvers (Other)
    • Site contact updated
    • Study description expanded, about 1 word
  7. Minor 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.
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function. The overall purpose of the ABVN Phase 1 grant is to evaluate the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate the effect of transcutaneous electrical stimulation of the auricular branch of the vagus nerve (ABVN) on compound nerve action potentials (CNAPs) in healthy subjects.
Trial Details
NCT Number NCT04206540
Lead Sponsor Indiana University
Collaborators: Purdue University, National Institutes of Health (NIH)
Conditions
(from sponsor)
Healthy Subjects
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov