Effect of Vagal Nerve Stimulation on Gastric Motor Functions

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06038929
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vagal nerve stimulant — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: vagal nerve stimulant
    The aim is to measure gastric emptying and gastric accommodation in response to a caloric meal in participants who have received insertion of the VNS for the treatment of medication - resistant depression.

Primary Outcome Measure

Gastric emptying T1/2 [ Time Frame: during 4 hour gastric emptying test ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Kathryn Vera, PhD
612-625-5018
Mayo Clinic in RochesterRochesterMinnesota55905
Paula Carlson, BS
507-284-2511
John Osborn, PhD (SUB_INVESTIGATOR)

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