NCT07798180 Transauricular Neurostimulation for Abdominal Pain Due to DGBI
| NCT ID | NCT07798180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nationwide Children's Hospital |
| Condition | Abdominal Pain (AP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-10-23 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Peter Lu, MD
PRINCIPAL INVESTIGATOR
Nationwide Children's Hospital
Frequently Asked Questions
Who can join the NCT07798180 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Abdominal Pain (AP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07798180 currently recruiting?
Yes, NCT07798180 is actively recruiting participants. Contact the research team at Peter.Lu@nationwidechildrens.org for enrollment information.
Where is the NCT07798180 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT07798180 clinical trial?
NCT07798180 is sponsored by Nationwide Children's Hospital. The principal investigator is Peter Lu, MD at Nationwide Children's Hospital. The trial plans to enroll 30 participants.