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Could a tiny ear device ease arthritis pain in kids?

NCT ID NCT05710640

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a small device that sends mild electrical pulses to the vagus nerve (through the ear) can reduce pain and inflammation in children with juvenile idiopathic arthritis. The trial planned to enroll children ages 5 to 18, but was terminated early after only 18 participants. The goal was to see if the active device worked better than a sham device at improving arthritis symptoms.

What this could mean

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

Active substance
transcutaneous vagus nerve stimulation (tcVNS) device
What this could lead to
If it works, this could offer a drug-free way to ease pain and inflammation for children with juvenile idiopathic arthritis.
What could go wrong
The trial was terminated early with only 18 participants, so results are very limited. The device may not work better than a sham (fake) treatment.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Jun 2023

Finished

Jan 2025

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

5 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: 1. Participant is 5 through 18 years of age (inclusive) at screening. 2. Regarding informed consent and compliance: 1. If 5 through 6 years of age, the participant's guardian is willing and able to understand and provide informed consent and comply with study protocol. 2. If 7 through 17 years of age, the participant is willing and able to sign assent and comply with study protocol, and the participant's guardian is willing and able to understand and provide informed consent and comply with study protocol. 3. If 18 years of age, the participant is willing and able to understand and provide informed consent and comply with study protocol. 3. The participant has a Juvenile Idiopathic Arthritis (JIA) diagnosis meeting International League of Associations for Rheumatology (ILAR) classification criteria with one of the following subtypes: 1. rheumatoid-factor negative polyarthritis 2. rheumatoid-factor positive polyarthritis 3. persistent oligoarthritis 4. extended oligoarthritis 5. psoriatic arthritis 6. enthesitis-related arthritis 7. systemic arthritis 4. The participant has \>=3 joints with active arthritis at screening 5. If the participant is receiving therapy for JIA at screening, that therapy is stable for the time period outlined below and is expected to remain stable for the duration of the study: a. stable dose for at least 1 week prior to screening: i. Oral steroids, \<= 0.2 mg/kg/day with a maximum 10 mg/day dose b. stable dose for at least 2 weeks prior to screening: i. NSAIDs c. stable dose for at least 8 weeks prior to screening: i. adalimumab ii. anakinra iii. canakinumab iv. certolizumab pegol v. etanercept vi. golimumab vii. infliximab viii. leflunomide ix. methotrexate x. tocilizumab d. stable dose for at least 12 weeks prior to screening: i. abatacept 6. If a female of child-bearing potential, the participant has a negative urine pregnancy test at screening 7. If of reproductive potential, must agree to abstinence or effective methods of birth control for the duration of the study Exclusion Criteria: 1. Other than NSAIDs or intra-articular injections, participant has been treated for JIA with lack of efficacy with: 1. More than 2 different classes of therapies, or 2. More than 3 medications in total 2. Participant has received high-dose steroids (\>=0.2 mg/kg/day) within the 28 days prior to screening. 3. Participant has had active systemic disease (fever, systemic rash) within the 3 months prior to screening including any of the following lab manifestations at screening: 1. Ferritin \>1000 ng/mL 2. White blood cell (WBC) ≥15,000/mm\^3 4. Participant has had an active acute systemic infection within 2 weeks of screening. involving fever (100.4⁰F or higher) for more than 24 hours, requirement for systemic antibiotics or antivirals, GI symptoms lasting 48 hours or more, or the need to hold second line medications for JIA (methotrexate or biologic). 5. Participant has a history of arrhythmia. 6. Participant has been diagnosed with postural orthostatic tachycardia syndrome (POTS). 7. Participant has received an intra-articular cortisone injection within the 28 days prior to screening. 8. Participant has received treatment with an investigational drug or device during the 28 days prior to screening or within five half-lives of the investigational drug prior to screening/baseline, whichever is the greater length of time. 9. Participant has received chronic treatment with an anti-cholinergic medication, including over the counter medications. 10. Participant has received treatment with rituximab: 1. Within one year of screening 2. At any time previously without documented B cell repletion 11. Participant has a comorbid disease that has required treatment with corticosteroids within the past year. 12. Participant has an implantable electronic device such as a pacemaker, defibrillator, hearing aid, cochlear implant, insulin pump or deep brain stimulator. 13. Participant has used cutaneous vagus nerve stimulation within 12 weeks prior to screening. 14. Participant has received a live attenuated viral vaccine within 28 days prior to screening or is expected to receive one during the study. 15. Participant has any condition which, in the opinion of the investigator, would jeopardize the participant's safety following exposure to a study intervention. 16. Participant has any past or current medical problems or findings from a physical examination or laboratory testing that are not listed above but which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or may impact the quality or interpretation of the data obtained from the study.

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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.

Contacts and locations

Locations

  • Division of Pediatric Rheumatology at the University of Utah School of Medicine and Primary Children's Hospital

    Salt Lake City, Utah, 84132, United States

  • Feinstein Institutes for Medical Research, Cohen Children's Medical Center: Pediatric Rheumatology

    Lake Success, New York, 11040, United States

  • Indiana University Medical Center: Riley Hospital for Children Department of Pediatric Rheumatology

    Indianapolis, Indiana, 46202, United States

  • Nemours Children's Health: Department of Pediatric Rheumatology

    Orlando, Florida, 32827, United States

  • Seattle Children's Hospital: Rheumatology Clinic

    Seattle, Washington, 98105, United States

  • Stephen D. Hassenfield Children's Center at NYU Langone Health

    New York, New York, 10016, United States

  • University of California San Francisco School of Medicine: Department of Pediatrics, Division of Pediatric Rheumatology

    San Francisco, California, 94158, United States

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