Actively Recruiting
Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome
Led by Medical College of Wisconsin · Updated on 2026-02-13
90
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
Sponsors
M
Medical College of Wisconsin
Lead Sponsor
U
University College, London
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 10 to 18 years old
- Children with functional upper gastrointestinal complaints and clinical suspicion for hypermobile Ehlers-Danlos Syndrome or Hypermobile Spectrum Disorders
- Beighton score of at least 4 out of 9 for joint hypermobility
- Children with functional upper gastrointestinal complaints and clinical suspicion for autonomic nervous system dysfunction
- English-speaking children without other explanations for symptoms
- Children and parents willing to participate and provide consent
You will not qualify if you...
- Medically complex children or those taking medications or having diseases explaining symptoms
- Children or parents with significant developmental delay
- Patients with organic diseases like peptic ulcer, H. pylori gastritis, celiac disease, inflammatory bowel disease, allergic or metabolic disorders causing chronic GI symptoms
- Treatment with new central nervous system drugs within two weeks prior to enrollment
- Pregnancy
- Chronic alcohol, illicit drug use, or smoking
- Severe dermatological conditions or infections of the ear (for pVNS therapy)
- Implanted electrical devices (for pVNS therapy)
- Hearing impairments (for aVNS therapy)
- Sight impairments without correction (for aVNS therapy)
- Seizure disorders (for aVNS therapy)
- Pacemakers, metal clips, or devices incompatible with MRI (for gastric motor function sub-study)
- Claustrophobia or inability to remain still during MRI
- Orthodontic braces or permanent retainers (for MRI sub-study)
- Inability to tolerate MRI noise
- Egg allergy or inability to complete standardized egg meal (for MRI sub-study)
- Bleeding disorders affecting biopsy (for HepGI Biobank sub-study)
- Recent antibiotic use (for fecal sample collection)
- Significant anemia or clinical issues preventing safe blood draw
- Refusal to provide blood or DNA samples
- Inability or unwillingness to provide clinical or family history
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
K
Katja Karrento, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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