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Ear device could ease gut woes in kids with bendy joint disorder

NCT ID NCT05212129

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a small, battery-powered device worn on the ear can reduce gastrointestinal symptoms in children aged 10-18 with hypermobile Ehlers-Danlos syndrome (hEDS) and related autonomic nervous system problems. The device, called IB-Stim, delivers gentle electrical pulses to a nerve in the ear to stimulate the vagus nerve. Researchers will measure changes in stomach symptoms, gastric function, and body awareness over six weeks. The goal is to find a non-drug treatment for the common gut issues that accompany hEDS.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
percutaneous vagal nerve stimulation device (IB-Stim)
What this could lead to
If it works, this could offer a drug-free way to reduce stomach and bowel symptoms in children with hypermobile Ehlers-Danlos syndrome.
What could go wrong
This is an early-stage, open-label trial with no placebo group, so results may be influenced by expectation. The device is already FDA-approved for other uses, but its benefit for this specific condition is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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