ABVN Phase 2-Studying the Effect of Stimulation on the Auricular Branch of the Vagal Nerve (ABVN2)

Indiana University

Status: Enrolling

Conditions: Gastroparesis

Treatments: Device: ML1101 Stimulus Isolator; Procedure: Vagal Maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT06491758

2006075899- A

Details and patient eligibility

About

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 by electrically stimulating the nerve around the external ear. If we can do this then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function

Full 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 stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Gastroparetic subjects will also undergo vagal maneuver using either the regular EKG electrodes or the MEA electrodes.

Subjects will also complete health history questionnaires.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Healthy Subjects

Experimental group

Description:

Subjects who have no gastric symptoms or conditions

Treatment:

Procedure: Vagal Maneuver

Device: ML1101 Stimulus Isolator

Gastroparesis Subjects

Experimental group

Description:

Subjects with a confirmed diagnosis of gastroparesis.

Treatment:

Procedure: Vagal Maneuver

Device: ML1101 Stimulus Isolator