ABVN Phase 2 - Ear Stimulation

Study acronym: ABVN2
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Enrollment reduced: 131 → 34 participants Show 8 more changesShow less
    • Start date: Jun 2, 2020 to Nov 5, 2020
    • Trial completed
    • Primary completion date changed from estimate of Dec 2028 to Mar 22, 2022
    • Interventions modified
    • Study description expanded, about 296 words
    • Collaborators expanded, about 7 words
    • Study title shortened, about 9 words
    • Eligibility criteria expanded, about 1 word
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 120 to confirmed 131
    • Site details revised
    v3
  3. Enrollment target: 330 to 120v2 Show 6 more changesShow less
    • Primary endpoints: 2 to 4
    • Interventions: Gastroelectric Stimulator (GES) (Device), PENFS- Percutaneous Electrical Nerve Field Stimulation (Other), TaVNS (Transcutaneous Auricular… to ML1101 Stimulus Isolator (Device), Vagal Maneuver (Procedure)
    • Secondary endpoints shortened, about 138 words
    • Study description shortened, about 692 words
    • Site contact updated
    • Study arms: 6 to 2
  4. 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 2 grant is to expand on previous work evaluating 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 vagus nerve on vagal nerve CNAPs and gastric hormones in healthy subjects and in subjects with gastroparesis.
Trial Details
NCT Number NCT06491758
Lead Sponsor Indiana University
Collaborators: Purdue University, National Institutes of Health (NIH)
Conditions
(from sponsor)		 Gastroparesis, Healthy Subjects
Related terms Gastroparesis
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov