Effect of stimulating the vagus nerve through the ear on stomach function
Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2
This study is testing if stimulating a nerve in the ear can help people with gastroparesis feel better by improving their stomach function and reducing symptoms like nausea and vomiting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT06491758 on ClinicalTrials.gov |
What this trial studies
This study investigates whether electrical stimulation of the auricular branch of the vagus nerve can improve stomach function in patients with gastroparesis. Participants will undergo transcutaneous stimulation and blood draws at various time points to assess the effects of the stimulation. Both healthy volunteers and gastroparetic subjects will be included, with specific procedures for each group to evaluate the impact of vagal maneuvers. The goal is to determine if this approach can alleviate symptoms such as nausea and vomiting associated with disordered stomach function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with a confirmed diagnosis of gastroparesis or healthy volunteers without gastric symptoms.
Not a fit: Patients who are pregnant, unable to provide consent, or prisoners will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for patients suffering from gastroparesis.
How similar studies have performed: While the approach of stimulating the vagus nerve is being explored in various contexts, this specific method of auricular stimulation for gastroparesis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Thomas V Nowak, MD — Indiana University
- Study coordinator: Maureen Schilling, BS
- Email: maschi@iu.edu
- Phone: 3172782064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.