ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve

Launched by INDIANA UNIVERSITY · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial, called the ABVN Phase 2 study, is investigating how stimulating a specific part of the vagus nerve—known as the auricular branch—can impact people with a condition called gastroparesis, which affects how the stomach moves food. The researchers want to see if this stimulation can change the way the vagus nerve works and how certain hormones related to digestion are produced. Both healthy volunteers and patients diagnosed with gastroparesis can participate in the study.

To be eligible, healthy volunteers should be between 18 and 80 years old and have no digestive issues. They must be comfortable having small electrodes placed on their ears and willing to have a little blood drawn during the study. For those with gastroparesis, they should also be in the same age range and have a formal diagnosis from a gastrointestinal doctor. Participants can expect to undergo non-invasive stimulation and will be monitored for changes in nerve activity and hormone levels. The trial aims to better understand how this treatment might help people with gastroparesis manage their symptoms.

Gender

ALL

Eligibility criteria

• • 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