Vagus nerve stimulation plus cognitive behavioral therapy to ease functional dyspepsia symptoms
Official title: Synergistic gut-brain axis modulation via vagal stimulation and cognitive behavioral therapy in functional dyspepsia
Funded at Spaulding Rehabilitation Hospital · NIH-11327318 · Data updated 2026-11-12
This project combines gentle vagus nerve stimulation with cognitive behavioral therapy to help adults with functional dyspepsia reduce stomach pain, fullness, and related anxiety.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Spaulding Rehabilitation Hospital NIH-funded |
| Lab location | 1 site (Charlestown, United States) |
| Project start | June 1, 2024 |
| Project end | March 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $728,747 |
| NIH project number | 5R01DK136243-03 |
| Project ID | NIH-11327318 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults aged 21 and older with a diagnosis of functional dyspepsia, especially those whose symptoms persist despite usual drug treatments, would be ideal candidates.
✕Less likely to help
People whose upper‑abdominal symptoms are explained by a clear structural disease or who cannot safely receive vagus nerve stimulation may not benefit from this approach.
What this research studies
If you join, you would be randomly assigned to receive sessions of noninvasive vagus nerve stimulation together with cognitive behavioral therapy or a comparison approach. You'll complete symptom and anxiety questionnaires and attend follow-up visits so researchers can track changes in gut symptoms and mood. The team will look at how a bottom-up nerve-based treatment and a top-down behavioral treatment might work together on brain–gut pathways. Participation involves a treatment schedule and monitoring visits over several months.
Why it matters
Potential benefit: If successful, the combined approach could offer a more effective treatment that reduces dyspepsia symptoms and related anxiety for patients who haven't benefited from standard medications.
How similar studies have gone: Behavioral therapies and vagus nerve stimulation have each shown benefit for some gut–brain disorders, but combining them is a relatively new idea with limited prior testing.
Where this research is happening
-
Spaulding Rehabilitation Hospital
Charlestown, United States Active
Researchers
- Principal investigator: Sclocco, Roberta — Spaulding Rehabilitation Hospital
- Study coordinator: Sclocco, Roberta
Related research
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Exploring the effects of vagal stimulation and therapy on gut-brain interactions in functional dyspepsia
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.