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
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|Condition or disease|
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 [Patient Registry]|
|Estimated Enrollment :||200 participants|
|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|
- 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
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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|
- At least 18 years of age.
- Documented diagnosis of gastroparesis.
- Will undergo implantation of a GES device or already has a GES device implanted
- History of allergic reaction to EKG lead placement adhesives.
- unable to give informed consent
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
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Thomas Nowak, MD||Indiana University|
|Responsible Party:||Thomas V. Nowak, MD, Indiana University|
|Other Study ID Numbers:||
|First Posted:||June 10, 2014 Key Record Dates|
|Last Update Posted:||December 19, 2019|
|Last Verified:||December 2019|
gastric electrical stimulator
Digestive System Diseases