Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels

Study acronym: TaVNS
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later May 31, 2026 → May 31, 2027
Primary endpoint reworded 7 of 7 changed
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Record History

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  1. Primary endpoint(s) modified Show 10 more changesShow less
    • Enrollment increased: 30 → 60 participants
    • Study completion moved earlier from May 31, 2028 to May 31, 2027
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Start date: Apr 16, 2025 to Apr 21, 2025
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description shortened, about 240 words
    • Site contact updated
    • Publications: details revised at 9 of 9 entries
  2. Primary completion pushed from May 31, 2026 to May 31, 2027
    • Study completion pushed from May 31, 2026 to May 31, 2028
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Eligibility criteria expanded, about 4 wordsv5
  5. Primary completion date: May 2026 to May 31, 2026
    • Study completion date: May 2027 to May 31, 2026
    • Start date: May 1, 2025 to Apr 16, 2025
    v4
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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Sep 2025 to May 2026
    • Study completion date: Sep 2026 to May 2027
    • Start date changed from estimate of Sep 2025 to May 1, 2025
    • Site details revised
  2. Primary endpoints: 3 to 7
    • Secondary endpoints: 1 to 3
    v2
  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.
The vagus or vagal nerve is a nerve that sends signals from the brain to other parts of the body to control involuntary functionm, including stomach function, and it is important to the regulation of insulin, C-peptide, and glucose levels. The purpose of this study is to evaluate whether electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve and influence the levels of insulin, C-peptide, and glucose. If it does, investigators hope that this will help innovate treatment of patients with nausea, vomiting, and disordered stomach function, and patients with diabetes.
Trial Details
NCT Number NCT06597149
Lead Sponsor Indiana University
Conditions
(from sponsor)		 Healthy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov