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Transauricular Neurostimulation for Abdominal Pain Due to DGBI

RecruitingNAAges 12 Years - 18 YearsAllNationwide Children's Hospital
NCT07798180 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transcutaneous auricular neurostimulation
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Where

1 site
Nationwide Children's Hospital
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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