Status:
RECRUITING
ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve
Lead Sponsor:
Indiana University
Conditions:
Gastroparesis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to find out if we can gain access to the vagus nerve which is largely an internal nerve that controls stomach function. We hope to gain access to the internal vagus nerve ...
Detailed Description
Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulatio...
Eligibility Criteria
Inclusion
- Inclusion Criteria healthy volunteers
- Healthy volunteers with no gastric symptoms or conditions (except due to COVID 19)
- Aged 18-80 years
- Willing to have electrodes placed in the external ear (ABVN arm)
- Willing to perform vagal activity maneuver (Vagal arm)
- Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points
- Inclusion Criteria gastroparesis subjects
- Gastroparesis subjects with a confirmed diagnosis of gastroparesis from a GI physician
- Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
- Aged 18-80 years
- Willing to have electrodes placed in the external ear (ABVN arm)
- Willing to perform vagal activity maneuver (Vagal arm)
- Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points
- Exclusion Criteria:
- Unable to provide consent
- Pregnant females
- Prisoners
Exclusion
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06491758
Start Date
June 2 2020
End Date
December 1 2030
Last Update
February 11 2025
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202