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

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ClinicalTrials.gov Identifier: NCT02159586
Recruitment Status : Unknown
Verified December 2019 by Thomas V. Nowak, Indiana University.
Recruitment status was:  Enrolling by invitation
First Posted : June 10, 2014
Last Update Posted : December 19, 2019
Sponsor:
Collaborator:
Purdue University
Information provided by (Responsible Party):
Thomas V. Nowak, Indiana University

Study Description
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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.

Condition or disease
Gastroparesis

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Cardiac Vagal Effects of Gastric Electrical Stimulation and Vagal Nerve Action Potentials in Vagus Nerve in Patients With Gastroparesis
Study Start Date : November 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159586


Locations
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United States, Indiana
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Purdue University
Investigators
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Principal Investigator: Thomas Nowak, MD Indiana University
More Information
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Additional Information:

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Responsible Party: Thomas V. Nowak, MD, Indiana University
ClinicalTrials.gov Identifier: NCT02159586    
Other Study ID Numbers: EKG/Vagal Nerve
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Keywords provided by Thomas V. Nowak, Indiana University:
gastroparesis
gastric electrical stimulator
GES
vomiting
 nausea
bloating
postprandial fullness
epigastric pain
Additional relevant MeSH terms:
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Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Paralysis
Neurologic Manifestations