Who may be eligible for this hypermobile Ehlers-Danlos syndrome clinical trial?

Children aged 10 to 18 years with functional upper gastrointestinal symptoms and suspected hEDS or autonomic nervous system dysfunction may be eligible. Participants must be English-speaking and have no other clear cause for their symptoms. Both boys and girls can join. Please review eligibility criteria for more details.

Is there any cost to participate in this hypermobile Ehlers-Danlos syndrome clinical trial?

Study-related care, including the study treatments and all trial visits, is provided at no cost. However, any personal travel expenses to and from study visits may vary and are not guaranteed to be covered by the trial.

Actively Recruiting

Phase Not Applicable

Age: 10Years - 18Years

All Genders

ID05212129

Study of Non-Invasive Vagal Nerve Stimulation to Improve Gastrointestinal Symptoms and Autonomic Function in Children and Teens with Hypermobile Ehlers-Danlos Syndrome

Q: What is this study trying to find out about hypermobile Ehlers-Danlos syndrome?

This study aims to understand the relationship between hypermobile Ehlers-Danlos syndrome (hEDS) and autonomic nervous system function. It evaluates whether two types of non-invasive vagal nerve stimulation therapies can reduce gastrointestinal symptoms and improve quality of life for people with hEDS and related conditions. The Medical College of Wisconsin leads this research to explore these new treatment approaches.

Led by Medical College of Wisconsin · Updated on 2026-02-13

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

Who Can Participate

Age: 10Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Children aged 10 to 18 years old
Children with functional upper gastrointestinal complaints and suspected hypermobile Ehlers-Danlos syndrome or Hypermobile Spectrum Disorder with a Beighton score of at least 4/9
Children with functional upper gastrointestinal complaints and suspected autonomic nervous system dysfunction
Children who are English-speaking
Children willing to participate with parental consent

You will not qualify if you...

Medically complex children or those taking medications or with diseases explaining symptoms
Significant developmental delay in children or their parents
Organic diseases like peptic ulcer, H. pylori gastritis, celiac disease, inflammatory bowel disease, allergic or metabolic disorders
New central nervous system active medication started within two weeks prior to enrollment
Pregnancy
Chronic alcohol or illicit drug use and smoking
Severe dermatological or ear infections for pVNS therapy
Implanted electrical devices for pVNS therapy
Hearing impairment, uncorrected sight impairment, or seizure disorder for aVNS therapy
MRI incompatibility issues or intolerance for gastric motor function sub-study
Egg allergy or inability to complete standardized egg meal for gastric sub-study
Bleeding disorders, recent antibiotic use, anemia, or refusal for blood or DNA sample collection in biobank sub-study
Inability or unwillingness to provide clinical or family history for biobank sub-study

Research Team

Katja Karrento, MD

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Study of Non-Invasive Vagal Nerve Stimulation to Improve Gastrointestinal Symptoms and Autonomic Function in Children and Teens with Hypermobile Ehlers-Danlos Syndrome

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria