Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Part of paid clinical trials in Minneapolis, Minnesota.
- Sponsor
- Mayo Clinic
- Study ID
- NCT06038929
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Vagal nerve stimulant — DEVICEVagus nerve stimulation involves using a device to stimulate the vagus nerve with electrical impulses. The implanted electrodes transmit electrical impulses travel to areas of the brain to treat conditions (intractable epilepsy, depression) and also send electrical impulses to the stomach.
Study Details
The specific aim of this study is to compare simultaneous assessment of gastric emptying and gastric accommodation in response to a caloric meal In patients who have previously undergone activation of left cervical VNS for the treatment of medication-resistant depression. Our hypothesis is that cervical VNS increases gastric accommodation and accelerates gastric emptying compared to a bank of healthy control data.
Key Dates
- Start date
- Sep 1, 2025
- Status verified
- Jul 2025
- Primary completion
- Jul 31, 2027
- Completion
- Dec 30, 2027
Study Design
- Enrollment
- 16 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: vagal nerve stimulantThe aim is to measure gastric emptying and gastric accommodation in response to a caloric meal in participants who have received insertion of the VNS for the treatment of medication - resistant depression.
Primary Outcome Measure
Gastric emptying T1/2 [ Time Frame: during 4 hour gastric emptying test ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | John Osborn, PhD (SUB_INVESTIGATOR) |
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