Actively Recruiting
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Led by Mayo Clinic · Updated on 2025-10-14
16
Participants Needed
2
Research Sites
121 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be at least 18 years old.
- Participant must be able to provide written informed consent and HIPAA authorization.
- Participant has drug-resistant epilepsy or treatment-refractory depression and has previously undergone VNS implantation.
- Participant has completed the REVEAL Common Study Protocol and is stabilized on a stable VNS setting.
- Participant is medically and neurologically stable apart from epilepsy or depression.
- Participant can complete regular office visits and telephone appointments including imaging sessions.
- Participants of childbearing potential must use acceptable birth control or abstinence during the study.
- Participant must be enrolled in active health insurance covering standard health care and injuries.
You will not qualify if you...
- Participant has a prior implantable stimulation device other than a VNS device.
- Participant currently uses or expects to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.
- Participant has Substance Use Disorder without 12 months or longer remission.
- Participant participated in another drug or device trial within the last 30 days (except REVEAL studies).
- Participant hospitalized for psychiatric condition within 6 months or history of psychosis within 2 years (excluding post-ictal psychosis).
- Participant experienced unprovoked status epilepticus in the past year.
- Participant unable or unwilling to use dominant arm or has upper arm circumference over 50 cm.
- Participant has certain clinical conditions such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension, POTS, uncontrolled sleep apnea, COPD, uncontrolled diabetes, pregnancy, or vocal cord paralysis.
- Participant cannot speak or read English.
- Participant is pregnant.
- Participant is on immunosuppressants, beta blockers, anticholinergics, or clonidine unless stable for 1 month.
- Participant weighs over 350 pounds (159 kg).
- Participant cannot eat eggs due to allergy, intolerance, or dislike.
- Any other factors impacting safety or compliance as determined by the investigators.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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