Effect of Vagal Nerve Stimulation on Gastric Motor Functions

NCT06038929 | Recruiting FDA Device

• 1 other identifier: 23-006558
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Epilepsy

Outcome Measures

Primary Outcomes (2)

• Gastric emptying T1/2

  time to empty 50% of the whole stomach contents

  during 4 hour gastric emptying test

• Gastric accommodation

  gastric delta volume (postprandial minus fasting) for the whole stomach

  during first 1 hour of gastric emptying test

Secondary Outcomes (8)

• Gastric emptying lag time

  1 day (during gastric emptying test)

• Gastric emptying 25%

  1 day (during gastric emptying test)

• Gastric emptying at 2 hours

  2 hours (during gastric emptying test)

• Gastric emptying at 4 hours

  4 hours (during gastric emptying test)

• Fasting whole volume volume

  baseline

Study Arms (1)

vagal nerve stimulant

EXPERIMENTAL

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.

Device: Vagal nerve stimulant

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.

vagal nerve stimulant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participant has a prior implantable stimulation device other than a VNS device for the clinical indication of refractory focal Epilepsy or for depression.
• Participant currently uses or during the study is expected to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.
• Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.
• Patient participated in another drug or device trial within the preceding 30 days (other than REVEAL studies).
• 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).
• Participant has experienced unprovoked status epilepticus in the preceding year.
• Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
• 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
• Participant with vocal cord paralysis
• Participant cannot speak and read English.
• Participant is pregnant.
• Prohibited Therapy During Study Period: We will exclude patients on immunosuppressants, beta blockers, anticholinergics, and clonidine. Consultation with primary providers and amending some of these therapies may be allowed only if clinically indicated. In that case, participants will have to be stable on their new medication for at least one month prior to implant.
• A body weight of over 350 pounds or 159 kilograms due to equipment limitations used in the measurements of gastric accommodation and emptying.
• An inability to eat eggs whether due to an allergy, intolerance, or strong dislike. The gastric emptying test meal contains eggs that are labeled with radioisotope. Other food substitutions for the toast, butter and milk may be made only if prior approval is given by Dr. Camilleri.
• Any other factor that may impact participant safety or compliance as per PI.

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Minnesota: collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Depression; Epilepsy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Michael Camilleri

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Pharmacology and Physiology

Model Details: Single cohort, open label study in 16 Vagus Nerve Stimulant-implanted subjects with drug-resistant epilepsy with seizures or depression, aged 18 years or older

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)