Vagal nerve stimulation for treating symptoms in children with hypermobile Ehlers-Danlos Syndrome
Hypermobile Ehlers-Danlos Syndrome: Efficacy of Non-invasive Vagal Nerve Stimulation and Effects on Brain-Gut Physiology
This study is testing two types of non-invasive vagal nerve stimulation therapies to see if they can help reduce gastrointestinal symptoms and improve the quality of life for children with hypermobile Ehlers-Danlos Syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT05212129 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two non-invasive vagal nerve stimulation therapies on gastrointestinal symptoms in children with Hypermobile Ehlers-Danlos Syndrome (hEDS) and related autonomic disorders. The study aims to explore the relationship between hEDS and autonomic regulation, focusing on symptom reduction and quality of life improvement. Participants will undergo treatments using a percutaneous vagal nerve stimulation device and acoustic vagal nerve stimulation. The research will also assess neurophysiological markers and the impact of these therapies on gastric function.
Who should consider this trial
Good fit: Ideal candidates are children aged 10-18 years with functional gastrointestinal complaints and clinical suspicion of hEDS or autonomic nervous system dysfunction.
Not a fit: Patients with medically complex conditions or those whose symptoms can be explained by other diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve gastrointestinal symptoms and quality of life for children with hEDS and related conditions.
How similar studies have performed: While the approach of using vagal nerve stimulation is being explored, this specific application for hEDS and related disorders is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 10-18 years old * Children with functional upper GI complaints and clinical suspicion for hEDS or HSD as well as a Beighton score of at least 4/9 * Children with functional upper GI complaints and clinical suspicion for ANS dysfunction * De-identified data from our prior studies (IRB #689519 and IRB #1064187) of patients with functional GI disorders who do NOT meet criteria for hEDS will be used as a comparison group * Children who are English-speaking and lack other explanation for symptoms * Children willing to participate and consent to this study (for children, have a parent willing to participate) Exclusion Criteria: A) Exclusion Criteria applying to all participants: * Medically complex children or those who take a medication or suffer from a disease that can explain symptoms will be excluded from participation in the study. * Adult subjects, children or their parents who have significant developmental delay (will be excluded due to difficulties in accurately completing the questionnaires and assessing symptoms) * Patients with findings of organic disease such as peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, metabolic disorder or any other chronic condition or medication that may cause chronic GI symptoms will be excluded from the study. * Patients who are treated with a new drug affecting the central nervous system in the two weeks prior to enrollment will also be excluded. * Pregnancy (evaluating MD screens patients as they normally would during a clinic visit (by questioning) and would only perform urine pregnancy test if clinically indicated (absence of menstrual period or other symptoms concerning for pregnancy) * Chronic alcohol/illicit drug use and/or smoking. B) Exclusion Criteria for subjects undergoing pVNS therapy: * Severe dermatological condition or active infection of external or middle ear * Implanted electrical device C) Exclusion Criteria for subjects undergoing aVNS therapy: * Hearing impaired * Sight impaired without correction * Seizure disorder D) Exclusion Criteria for subjects undergoing gastric motor function sub-study: * Patients with pacemakers, metal clips used in previous surgery or other device which are not compatible with MRI scanning * Claustrophobia or inability to lie still in the scanner * Orthodontic braces or permanent retainers * Patients who are unable to tolerate noise produced by the MRI * Egg allergy or anticipated inability to complete a standardized egg meal E) Exclusion Criteria for subjects undergoing HepGI Biobank specimen collection sub-study: * Bleeding disorder for the specific biopsies * Recent antibiotic usage for fecal sample * Significant anemia or clinical status which will not allow safe blood draw required for blood collection * Refusal of blood collection or to provide DNA sample * Inability or unwillingness on the individual (or parent/legal guardian) to provide clinical or family history.
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Katja Karrento, MD — Medical College of Wisconsin
- Study coordinator: Katja Karrento, MD
- Email: kkarrento@mcw.edu
- Phone: (414) 266-3690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.