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

What this Trial Is About

Researchers are studying Hypermobile Ehlers-Danlos Syndrome (hEDS), a connective tissue disorder that causes very flexible skin and joints, along with other tissue issues. This condition often comes with gastrointestinal and autonomic nervous system problems, such as postural orthostatic tachycardia syndrome (POTS). The study explores the link between hEDS and autonomic regulation and evaluates if two types of non-invasive vagal nerve stimulation therapies can reduce gastrointestinal symptoms in people with hEDS and POTS. It also examines how these therapies might affect stomach function and nerve signaling. The study involves two groups of participants. One group of 60 children with hEDS or Hypermobile Spectrum Disorder will participate in a four-week, randomized, double-blind trial listening to either special filtered vocal music designed to stimulate vagal nerve calming (active therapy) or regular music (sham therapy). The other group of 30 children with autonomic nervous system dysfunction will receive a six-week open-label treatment using a device called IB-Stim, which provides low voltage nerve stimulation through electrodes on the ear. Some participants may also undergo a gastric MRI scan and provide blood samples for additional research. Participants will be assessed before, during, and after therapy using questionnaires about gastrointestinal symptoms, body perception, and nerve function. The study measures changes in these symptoms and uses imaging to observe stomach motor function. Monitoring includes questionnaires and physiological tests over about six weeks of therapy. The trial runs until the end of 2026, and researchers will review outcomes like symptom improvement and nerve efficiency to understand effects of these therapies on hEDS and related autonomic issues.

Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome