REVEAL - Research Evaluating Vagal Excitation and Anatomical Linkages Gastric Emptying Ancillary Project: Effect of Vagal Nerve Stimulation on Gastric Motor Functions
Mayo Clinic
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.
Description
Objectives To compare simultaneous assessment of gastric emptying and gastric accommodation in response to the same caloric meal in patients who have undergone activation of left cervical Vagal Nerve Stimulation. Design and Outcomes Single cohort study in 12 Vagus Nerve Stimulant-implanted subjects with drug-resistant depression, aged 18 years or older who were consented for the main VESPA REVEAL Common Study Protocol. There is only 1 visit needed, with an average time commitment of 4.5 hours. Participants will have completed their planned VESPA REVEAL study visits Interventions and Duration…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, participa…
Interventions
- DeviceVagal nerve stimulant
Vagus 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.
Locations (2)
- University of MinnesotaMinneapolis, Minnesota
- Mayo Clinic in RochesterRochester, Minnesota