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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK136243 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensory device + Skills Building | Experimental |
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| Sensory device + Health Education | Active Comparator |
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| Subsensory device + Skills Building | Active Comparator |
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| Subsensory device + Health Education | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensory device | Device | Sensory vagal nerve stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Visceral Sensitivity Index (VSI) | GI-related anxiety; score ranging from score ranging from 0 to 75, with higher scores indicating worse outcomes | 8 weeks (post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric peristaltic velocity | MRI-derived gastric motility outcome | 8 weeks (post-treatment) |
| Nepean Dyspepsia Index (NDI) | FD symptoms severity; score ranging from 0 to 100, with higher scores indicating worse outcomes |
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Inclusion Criteria:
Age 18-65 years old (inclusive)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noah Naddaff-Slocum | Contact | 617-724-6086 | convergestudy@mgb.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02129 | United States |
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| Skills Building | Behavioral | Skills Building behavioral therapy |
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| Health Education | Behavioral | Education of FD condition |
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| Subsensory device | Device | Subsensory vagal nerve stimulation |
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| 8 weeks (post-treatment) |