Cardiac Vagal Effects of GES in Patients With Gastroparesis and Vagal Nerve Action Potentials in Vagus Nerve

NCT02159586 | Completed FDA Device

• 2 other identifiers: EKG/Vagal Nerve1206008988
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if Gastric Electrical Stimulation may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System.

Conditions

Gastroparesis

Keywords

gastroparesis; gastric electrical stimulator; GES; vomiting; nausea; bloating; postprandial fullness; epigastric pain

Outcome Measures

Primary Outcomes (1)

• Determine if GES influences vagal outflow

  To determine if GES may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System; EKG electrodes will be placed on the chest, stomach, jugular, and vagas nerves. The purpose of this is to record the effects of the stimulator when on and off. The ECG signals are digitized with an ECG power amplifier, Power Lab by AD Instruments. The digitized signals are analyzed with an ECG software analysis system, Lab Chart. The analysis will look for heart rate variability, total power variability, and frequency variability. This will determine if stimulation has an effect on these levels.

  2-3 years

Secondary Outcomes (2)

• Release of hormones

  2-3 years

• Vagus nerve anatomy

  2-3 years

Study Arms (1)

GES subjects

male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device

Device: gastric electrical stimulator

Interventions

gastric electrical stimulator DEVICE

GES subjects

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will evaluate male and female patients at least 18 years of age, with gastroparesis, who will or have already undergone the implantation of a GES device (Enterra, Medtronic, Minneapolis, MN)

You may qualify if:

• At least 18 years of age.
• Documented diagnosis of gastroparesis.
• Will undergo implantation of a GES device or already has a GES device implanted

You may not qualify if:

• Pregnancy
• History of allergic reaction to EKG lead placement adhesives.
• unable to give informed consent

Sponsors & Collaborators

• Purdue University: collaborator
• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be withdrawn to assess the hormones like insulin, cholecystokinin and serotonin

MeSH Terms

Conditions

Gastroparesis; Vomiting; Nausea

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Thomas Nowak, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 10, 2014
• Study Start: November 1, 2012
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: October 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)