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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT06360900
Status
Recruiting
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Conditions

  • Functional Dyspepsia

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Sensory device — DEVICE
    Sensory vagal nerve stimulation
  • Skills Building — BEHAVIORAL
    Skills Building behavioral therapy
  • Health Education — BEHAVIORAL
    Education of FD condition
  • Subsensory device — DEVICE
    Subsensory vagal nerve stimulation

Study Details

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.

Key Dates

Start date
Oct 29, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Sensory device + Skills Building
  • Active Comparator: Sensory device + Health Education
  • Active Comparator: Subsensory device + Skills Building
  • Sham Comparator: Subsensory device + Health Education

Primary Outcome Measure

Visceral Sensitivity Index (VSI) [ Time Frame: 8 weeks (post-treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02129
Karen Lin
[email protected]
617-724-6642

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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