Trials / Recruiting
RecruitingNCT06360900
Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Spaulding Rehabilitation Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sensory device | Sensory vagal nerve stimulation |
| BEHAVIORAL | Skills Building | Skills Building behavioral therapy |
| BEHAVIORAL | Health Education | Education of FD condition |
| DEVICE | Subsensory device | Subsensory vagal nerve stimulation |
Timeline
- Start date
- 2025-10-29
- Primary completion
- 2029-03-01
- Completion
- 2029-03-01
- First posted
- 2024-04-11
- Last updated
- 2025-11-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06360900. Inclusion in this directory is not an endorsement.