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Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

This study is looking at two ways to use vagal nerve stimulation (VNS) to help children aged 10-18 with hypermobile Ehlers-Danlos Syndrome (hEDS) or Hypermobile Spectrum Disorders (HSD) who also have stomach and gut issues, and possibly problems with their autonomic nervous system (which controls automatic body functions). Researchers want to see if using an FDA-approved device called IB-Stim (percutaneous vagal nerve stimulation, or pVNS) or listening to special music (acoustic vagal nerve stimulation, or aVNS) can reduce these gastrointestinal symptoms. The main goal is to see how much gut symptoms improve after 6 weeks of treatment with IB-Stim or 4 weeks with aVNS. The study plans to enroll 90 participants and is currently unclear about its recruitment status.

Study design
This study involves different approaches: some participants will receive an open-label treatment with the IB-Stim device for six weeks, while others will be randomly assigned to receive either active or sham acoustic vagal nerve stimulation for four weeks in a double-blind manner. The study plans to enroll 90 participants.
What's involved
Participants in the IB-Stim group will have a six-week treatment period. Participants receiving acoustic therapy will have a four-week treatment period.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for gastrointestinal symptoms is measured at the end of therapy, which is 6 weeks for one treatment and 4 weeks for another.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05212129

Auricular Vagal Nerve Stimulation for Hypermobile Ehlers-Danlos Syndrome

Recruiting
NAAges 10–18InterventionalTreatment
Medical College of Wisconsin
~90 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:Percutaneous vagal nerve stimulation (pVNS) deviceAcoustic vagal nerve stimulation (aVNS) treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in gastrointestinal symptoms as assessed by the instrument Patient Assessment of upper Gastrointestinal Symptom Severity Index (PAGI-SYM)
Measured over Change from baseline total PAGI-SYM score at end of therapy (6 weeks)

Conditions

Functional Gastrointestinal Disorders
Hypermobile Ehlers-Danlos Syndrome
Postural Orthostatic Tachycardia Syndrome
Autonomic Nervous System Disease
Autonomic Nervous System Imbalance

Explore related trials

Disorder of autonomic nervous systemEhlers-Danlos Syndrome, Type IIIFunctional disorder of gastrointestinal tractPostural Orthostatic Tachycardia Syndrome

NCT05212129

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Medical College of Wisconsin

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Katja Karrento, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin

Who to contact

Katja Karrento, MD
[email protected]
(414) 266-3690
Email the study team

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Eligibility criteria

Inclusion

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

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.
Severe dermatological condition or active infection of external or middle ear
Implanted electrical device
Hearing impaired
Sight impaired without correction
Seizure disorder
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
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.

What this trial measures

  • Change in gastrointestinal symptoms as assessed by the instrument Patient Assessment of upper Gastrointestinal Symptom Severity Index (PAGI-SYM)Change from baseline total PAGI-SYM score at end of therapy (6 weeks)

    Instrument assessing upper gastrointestinal symptoms including symptoms of gastroparesis; score range 0-100 with higher scores indicating worse symptoms