Transauricular Neurostimulation for Abdominal Pain in Teens
Official title: Transauricular Neurostimulation for Irritable Bowel Syndrome
Run by Nationwide Children's Hospital · NCT07798180 · Data updated 2026-11-12
We are testing a head- and ear‑based device to see if it helps teens with abdominal pain from gut-brain disorders.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 18 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | October 23, 2025 |
| Main results expected | October 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07798180 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents aged 12–18 with a Rome IV diagnosis of a DGBI and average abdominal pain ≥3/10, who can tolerate the Sparrow earpiece and speak English.
✕Probably not a fit
Participants with contraindications to neuromodulation, abnormal ear anatomy preventing device use, or unstable medical/psychiatric conditions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-site, open-label pilot study enrolling adolescents aged 12 to 18 with abdominal pain related to disorders of gut-brain interaction. Participants will use the Sparrow Link transcutaneous auricular neurostimulation device for at least one hour daily for four weeks, with follow-up through week 8 to monitor safety, adherence, and changes in pain, bowel symptoms, quality of life, and anxiety. Up to 30 participants may enroll, aiming for about 20 to complete the study. The trial will provide preliminary data on feasibility and potential signals of benefit to guide future research.
Why it matters
Potential benefit: If successful, the device could offer a non-drug option to reduce abdominal pain and improve daily functioning for adolescents with DGBI.
How similar studies have gone: Prevailing neuromodulation approaches have shown promise in related gastrointestinal disorders, but this specific transauricular method in adolescents is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 12-18 years. * Clinical diagnosis of an abdominal pain-related disorder of gut-brain interaction (DGBI) meeting Rome IV criteria. * Average abdominal pain intensity ≥3 on a 0-10 scale and pain on at least 2 days per week. * Proper fit of the Sparrow earpiece on the left ear, as determined by study personnel. Exclusion Criteria: * Medical or psychiatric condition that contraindicates transauricular neurostimulation or creates a safety risk. * Abnormal ear anatomy preventing earpiece placement. * Developmental delay. * Implanted electronic device or hearing aid. * Participation in another interventional trial. * Pregnancy * Unable to communicate in English. * Prisoner. * Change in medications used to treat abdominal pain or gastrointestinal symptoms within 2 weeks before enrollment. Participants must be on stable doses for at least 2 weeks before enrollment.
Where it's running
-
Nationwide Children's Hospital
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Peter Lu, MD — Nationwide Children's Hospital
- Study coordinator: Peter Lu, MD
- Email: Peter.Lu@nationwidechildrens.org
- Phone: (614) 722-3421
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.