NCT06038929

Effect of Vagal Nerve Stimulation on Gastric Motor Functions

REVEAL - Research Evaluating Vagal Excitation and Anatomical Linkages Gastric Emptying Ancillary Project: Effect of Vagal Nerve Stimulation on Gastric Motor Functions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 In this single cohort study in 12 Vagus Nerve Stimulant-implanted subjects, each participant will undergo combined gastric emptying/accommodation test after completing the Visits required in CSP Sample Size and Population Sample size assessment. This will be based on results of the primary endpoints in our Mayo Clinic lab. We expect 80% power, α=0.05, assuming unpaired t-test analysis with n=12 in patients receiving VNS compared to the healthy control data (n=300 for both gastric emptying and gastric volume . Demonstrable differences (Table 1) will be based on the variation (SD) observed from our Mayo Clinic prior studies. Table 1A. Effect size demonstrable for primary endpoints of interest, based on 80% power at α=0.05 (for n=12 with p-VNS): PRIMARY ANALYSIS Response Meal SD Effect size detectable \[absolute (% of mean)\] Fasting gastric volume, mL 273 57 471mL (17.3%) Postmeal gastric volume, mL 848 111 92mL (10.8%) GE of solids T1/2, min 122 29.8 24.7 min (20.2%) In addition, these effect sizes are feasible in response to vagal intervention, whether it turns out to be stimulatory or inhibitory, and a 26-minute difference in GE T1/2 is clinically significant, as documented in a published meta-regression from our research team. Human subjects. Participants will be recruited primarily from the University of Minnesota (90-minute drive away). With only limited added burden on participants, who will previously have undergone placement of vagal nerve stimulator. There is only 1 total visits needed, with an average time commitment of 4.5 hours. The patients will have undergone placement of the VNS for clinical indications. The objective of the study is to evaluate the effects of this treatment on gastric functions, rather than any therapeutic intent, or the development of a new indication to be submitted to regulatory agencies for an additional therapeutic indication. Therefore, it is perceived that an application for an investigational device exemption (IDE) is not required.

Conditions

• Depression
• Epilepsy

Interventions

Type	Name	Description
DEVICE	Vagal 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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-07-31
• Completion: 2027-12-30
• First posted: 2023-09-15
• Last updated: 2025-10-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study