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Transauricular Neurostimulation for Abdominal Pain Due to DGBI

Transauricular Neurostimulation for Irritable Bowel Syndrome

Who can join

Ages 12 to 18 · All sexes

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.

About the study

This single-site, open-label pilot study will evaluate transcutaneous auricular neurostimulation using the Sparrow Link device as a treatment for adolescents aged 12 to 18 years with abdominal pain related to disorders of gut-brain interaction. Up to 30 participants will be enrolled, with a goal of 20 completing the study. Participants will use the device for at least one hour daily for 4 weeks and complete questionnaires through week 8. The study will assess adherence, retention, safety, and preliminary changes in abdominal pain, bowel symptoms, quality of life, and anxiety.

What is being tested

• Transcutaneous auricular neurostimulation (device)

Sponsor: Nationwide Children's Hospital · Participants: 30 · Started: Oct 23, 2025

Contact the study team

• Peter Lu, MD · Phone: (614) 722-3421
• Eduardo Castillo Leon, MD · Phone: 617-722-3874

Official record on ClinicalTrials.gov — NCT07798180

Locations in the U.S.

Conditions

• Abdominal Pain

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.