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Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia

Study acronym: CONVERGE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site contact updatedv6
  2. Site contact updatedv5
  3. Interventions: CBT (Behavioral), Education Control (Behavioral), Sham taVNS (Device), taVNS (Device) to Health Education (Behavioral), Sensory device (Device), Skills Building (Behavioral), Subsensory device (Device)
    • Collaborators expanded, about 10 words
    • Study title shortened, about 1 word
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Jun 2025 to Oct 29, 2025
    • Primary endpoints: 2 to 1
    • Study sites: 0 to 1
    • Secondary endpoints: 1 to 2
  5. Start date: Jun 2024 to Jun 2025v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.
Trial Details
NCT Number NCT06360900
Lead Sponsor Spaulding Rehabilitation Hospital
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Functional Dyspepsia
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov