RecruitingDepressionEpilepsy
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ 1. Participant must be at least 18 years old.
- ✓ 2. Participant must have the capacity to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.
- ✓ 3. Participant must be enrolled in an active health insurance plan that will cover the costs associated with standard health care services and injuries.
- ✓ 4. Participant must have been previously implanted with a VNS device for the clinical indication of Major Depressive Disorder (MDD).
- ✓ 5. Participant must have a score on the baseline administration of the Montgomery-Åsberg Depression Rating Scale (MADRS) of ≥ 22.
- ✓ 6. Participant must be able and willing to complete the evaluations and procedures described in the study protocol.
- ✓ 7. Participant must be able and willing to follow the stipulations regarding concomitant medications and excluded medications described in section 5.3 of the study protocol.
- ✓ 8. Participant that is of childbearing potential must be adequately protected from conception or willing to use an acceptable method of birth control over the entire study duration (acceptable birth control includes abstinence, barrier methods, hormonal methods, sterilization and fertility awareness).
You may not qualify if…
- ✕ 1. Participant has a prior implantable stimulation device other than a VNS device for the clinical indication of refractory focal Epilepsy or for depression.
- ✕ 2. Participant currently uses or during the study is expected to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.
- ✕ 3. Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.
- ✕ 4. Patient participated in another drug or device trial within the preceding 30 days (other than REVEAL studies).
- ✕ 5. Participant has been hospitalized for a psychiatric condition within the preceding 6 months or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).
- ✕ 6. Participant has experienced unprovoked status epilepticus in the preceding year.
- ✕ 7. Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
- ✕ 8. Any other clinical reasons deemed by the investigators of the study for which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes or pregnancy
Where it's recruiting
Minnesota
Minneapolis · Rochester
Source: ClinicalTrials.gov · NCT06038929 · last updated 2025-10-14