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Recruiting NCT06038929

Effect of Vagal Nerve Stimulation on Gastric Motor Functions

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Trial Parameters

Condition Depression
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase N/A
Enrollment 16
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-09-01
Completion 2027-07-31
Interventions
Vagal nerve stimulant

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Brief Summary

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.

Eligibility Criteria

General criteria 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 is diagnosed with drug Resistant Epilepsy and previously underwent implantation of VNS. and/or 4. Participant is diagnosed with treatment-refractory depression and previously underwent implantation of VNS. 5. Participant has completed the REVEAL CSP and has been stabilized by their care team on a stable VNS setting 6. Apart from epilepsy or depression, participant should be medically and neurologically stable. 7. Participant is able to complete regular office visits and telephone appointments including the imaging session in accordance with the study protocol requirements. 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 (accepta

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