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

Gastroparesis Clinical Trial

— GES  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02159586
• Other study ID #: EKG/Vagal Nerve
• Status: Enrolling by invitation
• Start date: November 2012
• Est. completion date: December 2020

Study information

• Verified date: December 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if GES influences vagal outflow	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