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RecruitingNot ApplicableNCT05212129

Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

Hypermobile Ehlers-Danlos Syndrome: Efficacy of Non-invasive Vagal Nerve Stimulation and Effects on Brain-Gut Physiology

Sponsor

Medical College of Wisconsin

Enrollment

90 participants

Start Date

Apr 5, 2021

Study Type

INTERVENTIONAL

Conditions

Postural Orthostatic tachycardia SyndromeFunctional Gastrointestinal DisordersAutonomic Nervous System DiseaseHypermobile Ehlers-Danlos SyndromeAutonomic Nervous System Imbalance

Summary

Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue disorder characterized by hyperextensible skin, joint hypermobility and additional connective tissue manifestations. For unclear reasons, hEDS is associated with many gastrointestinal (GI) and autonomic nervous system (ANS) complaints such as postural orthostatic tachycardia syndrome (POTS). This study will address the clinical relationship between hEDS/Hypermobile Spectrum Disorders and autonomic regulation and see if there is a benefit of two forms of non-invasive vagal nerve stimulation therapies to reduce GI symptoms in hEDS and POTS. The study will also investigate plausible effects of these nerve stimulation therapies on gastric function and autonomic signaling.

Eligibility

Min Age: 10 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether auricular (ear-based) vagus nerve stimulation can help children with hypermobile Ehlers-Danlos Syndrome (hEDS) or hypermobility spectrum disorder who have upper gastrointestinal symptoms like nausea, vomiting, or stomach pain. The gentle device stimulates a nerve near the ear to try to regulate the gut-brain connection. You may be eligible if... - Your child is between 10 and 18 years old - Your child has functional upper GI problems (nausea, stomach pain, vomiting) - Your child has clinical signs consistent with hEDS or hypermobility spectrum disorder (Beighton score of at least 4/9) - Your child speaks English You may NOT be eligible if... - Your child has a diagnosed organic GI disease (e.g., celiac disease, inflammatory bowel disease, peptic ulcer) - Your child has an implanted electrical device or pacemaker - Your child is pregnant - Your child has a seizure disorder - Your child has significant developmental delay Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPercutaneous vagal nerve stimulation (pVNS) device

Subjects in Treatment Arm B will enter a six-week, prospective open label treatment trial with the FDA-approved and commercially available device IB-Stim. This is an ambulatory, neurostimulation device which consists of a battery powered, externally affixed generator with 4 wire leads attached to electrode/needle arrays affixed to the outer ear. The device delivers low voltage (3.2V) stimulation in alternating frequencies for a total of 5 days (around the clock).

OTHERAcoustic vagal nerve stimulation (aVNS) treatment

All subjects receiving acoustic therapy via active VNS (aVNS; n=30) or sham VNS (sVNS; n=30) will enter a four-week, randomized, double-blind clinical trial during which they will listen to either computer altered/filtered vocal music (active treatment) that has been designed to stimulate vagal calming vs. regular non-filtered music (sham treatment). The stimuli will mirror the acoustic intervention known as the Safe and Sound Protocol. This protocol has been found to reduce auditory hypersensitivities and calming the autonomic nervous system by increasing vagal regulation of the heart via brainstem ventral vagal complex. The acoustic intervention may be played by an electronic device (i.e. smartphone, tablet, laptop, mp3) and delivered virtually with the help of trained coaches.

Locations(1)

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT05212129

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