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
Abstract
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.
Conditions: Ehlers-Danlos Syndrome, Healthy Subjects.
Primary outcome: Amplitude of vagal nerve compound action; Respiratory Changes in heart rate during stimulation; Changes in amplitude of the surface electrogastrogram.
Enrollment: 58 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 58 participants or records.
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