ABVN Phase 2 - EDS Wearable Device

NCT07856459 | Completed DMC FDA Device

• 2 other identifiers: 2006075899-E1OT2OD028183-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ehlers-Danlos Syndrome; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Amplitude of vagal nerve compound action

  To measure the amplitude of vagal nerve compound action potentials during transcutaneous stimulation of the auricular branch of the vagal nerve.

  3 hours

• Respiratory Changes in heart rate during stimulation

  To measure respiratory changes in heart rate during transcutaneous stimulation of the auricular branch of the vagal nerve.

  3 hours

• Changes in amplitude of the surface electrogastrogram

  To measure the changes of surface electrogastogram during transcutaneous stimulation of the auricular branch of the vagal nerve.

  3 hours

Other Outcomes (1)

• Feasibility of CardioWatch to predict or detect the onset of symptoms

  Daily for four weeks

Study Arms (2)

Healthy Subjects

EXPERIMENTAL

Subjects who have no gastric symptoms or conditions

Device: ML1101 Stimulus Isolator; Device: Cardiowatch Bracelet

Ehlers-Danlos Syndrome (EDS) Subjects

EXPERIMENTAL

Subjects with a confirmed diagnosis of EDS.

Device: ML1101 Stimulus Isolator; Device: Cardiowatch Bracelet

Interventions

ML1101 Stimulus Isolator DEVICE

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.

Ehlers-Danlos Syndrome (EDS) Subjects; Healthy Subjects

Cardiowatch Bracelet DEVICE

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.

Also known as: Corsano Wearable Platform

Ehlers-Danlos Syndrome (EDS) Subjects; Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers with no major medical conditions including heart disease, lung disease, cancer, EDS or GI disease
• Aged 18-80 years
• Willing to have electrodes placed in the external ear
• Willing to wear the watch for 4 weeks continuously

You may not qualify if:

• Unable to provide consent
• Pregnant females
• Prisoners
• Have a formal diagnosis of EDS
• Aged 18-80 years
• Willing to have electrodes placed in the external ear
• Willing to wear the watch for 4 weeks continuously
• Unable to provide consent
• Not having a diagnosis of EDS
• Pregnant females
• Prisoners

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Thomas V Nowak, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: July 30, 2024
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: Three years after study completion
• Access Criteria: None as of yet.

Locations

US (1)