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

December 18, 2019 updated by: Thomas V. Nowak, Indiana University

Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus Nerve in Patients With Gastroparesis

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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

The study will be conducted at one center and approximately 200 subjects will be enrolled.

Subjects undergoing the GES implantation will be enrolled before the implantation and may have a baseline visit. The visit procedures will be conducted at the discretion of the investigator dependent on the clinical condition of the patient at that time.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if GES influences vagal outflow
Time Frame: 2 years

The objective of this study is to determine if GES may influence vagal outflow via vagal afferent fibers that terminate in the Central Nervous System (CNS).

The development of a method to record and analyze compound action potentials from the vagus nerve will enhance our knowledge of the mechanism of action of Vagal Nerve Stimulation (VNS) in the treatment of gastroparesis. In addition, noninvasive measures of vagus nerve excitability are an important initial step towards 1) improved stimulus parameter tuning protocols in new device recipients before direct nerve recording technology is available, 2) a method of monitoring the nerve response over extended periods of time to ensure optimal device settings for the duration of the implantation, and 3) the development of completely noninvasive VNS device option. Furthermore, the technique itself may be of value in other clinical settings in which it would be useful to evaluate the physiological integrity of the vagus nerve
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Purdue University

Investigators

  • Principal Investigator: Thomas Nowak, MD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKG/Vagal Nerve

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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