Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06009159 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Vagus Nerve Stimulation(VNS) As Treatment For Fibromyalgia Patients

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Jul 31, 2026 → Jul 31, 2029
See other at-risk trials from Massachusetts General Hospital

Record History

  1. Primary completion pushed from Jul 31, 2026 to Jul 31, 2029 Completion pushed from Oct 31, 2026 to Oct 31, 2029v7 Show 1 more changeShow less
    • Completion pushed from Oct 31, 2026 to Oct 31, 2029
  2. Primary completion date: Dec 31, 2025 to Jul 31, 2026 Completion date: Mar 31, 2026 to Oct 31, 2026v6 Show 1 more changeShow less
    • Completion date: Mar 31, 2026 to Oct 31, 2026
  3. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 30 to 60 · Study sites: 0 to 1 · Primary completion date: Oct 31, 2025 to Dec 31, 2025 · 4 morev5 Show 7 more changesShow less
    • Enrollment target: 30 to 60
    • Study sites: 0 to 1
    • Primary completion date: Oct 31, 2025 to Dec 31, 2025
    • Completion date: Dec 31, 2025 to Mar 31, 2026
    • Start date changed from estimate of Aug 1, 2024 to Jul 1, 2024
    • Eligibility criteria revised
    • Study description shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  4. Secondary endpoints revised (6)v4 See this version in full on ClinicalTrials.gov ↗
  5. Start date: Oct 1, 2023 to Aug 1, 2024 Secondary endpoints: 4 to 6v3 Show 1 more changeShow less
    • Secondary endpoints: 4 to 6

    See this version in full on ClinicalTrials.gov ↗

  6. Primary endpoint revised Secondary endpoints: 5 to 4 · Study description expanded, about 1 wordv2 Show 2 more changesShow less
    • Secondary endpoints: 5 to 4
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Fibromyalgia (FM) is a syndrome with clinical symptoms involving multiple systems. The efficacy of current treatments is inadequate, and more alternative modalities are needed for the management of FM patients. The parasympathetic vagus nerve innervates and integrates sensory, motor, and autonomic systems and has been suggested to play a role in pain modulation. The role of vagus nerve stimulation (VNS) as a treatment option for FM patients is yet to be investigated. The investigators propose to examine the hypothesis that vagus nerve stimulation could improve pain and related comorbid symptoms for FM patients.
Trial Details
NCT Number NCT06009159
Lead Sponsor Massachusetts General Hospital
Conditions Fibromyalgia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov