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Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

Study acronym: VNS in PTSD
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
See other at-risk trials from VA Office of Research and Development

Record History

  1. Notable Primary endpoint(s) modified Interventions modified · Eligibility criteria expanded, about 14 words · Secondary endpoints: details revised at 1 of 2 entries · 1 more Show 4 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
  2. Notable Primary completion date: Jul 1, 2026 to Jul 8, 2027 Primary endpoints revised (2) · Completion date: Nov 17, 2026 to Nov 10, 2027 · Interventions: sham (Device), tcVNS (Device) to Sham (Device), tcVNS (Device) · 2 morev6 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Completion date: Nov 17, 2026 to Nov 10, 2027
    • Interventions: sham (Device), tcVNS (Device) to Sham (Device), tcVNS (Device)
    • Secondary endpoints revised (2)
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Completion date: Sep 15, 2026 to Nov 17, 2026v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Minor Site details revisedv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.
Trial Details
NCT Number NCT05517304
Lead Sponsor VA Office of Research and Development
Conditions Stress Disorders, Post-Traumatic
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov