Clinical Research Directory
Browse clinical research sites, groups, and studies.
ABVN Phase 2 - EDS Wearable Device
Sponsor: Indiana University
Summary
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function. The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate autonomic responses in Ehlers-Danlos Syndrome patients and healthy participants during transcutaneous electrical stimulation of the vagus nerve and during normal daily activities.
Official title: Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials (CNAPs) Phase 2 - EDS Wearable Device
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2024-07-30
Completion Date
2025-10-24
Last Updated
2026-10-02
Healthy Volunteers
Yes
Conditions
Interventions
ML1101 Stimulus Isolator
Electrical stimulation of the vagus nerve around the external ear using a transcutaneous device. Electrical current will be increased or decreased in intensity based on subject feedback. Once the target level has been achieved the stimulation will be delivered for 2 minutes.
Cardiowatch Bracelet
The Corsano CardioWatch System is a remote patient monitoring system that consists of a monitoring bracelet device worn on the wrist, a web-based browser platform, and a user mobile application. The bracelet continuously monitors vital sign data (pulse rate, oxygen saturation, body temperature, blood pressure) and activity levels (motion / step) from the individual being monitored and securely transmits the encrypted data to a secure server.
Locations (1)
Indiana University
Indianapolis, Indiana, United States