Overview
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
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.
