NCT07798180NARecruiting
Transauricular Neurostimulation for Abdominal Pain Due to DGBI
Nationwide Children's Hospital
Start Date
10/23/2025
Completion Date
10/30/2026
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
Age Range: 12 years to 18 years
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.
Interventions
DEVICE
Transcutaneous auricular neurostimulation
Conditions
Abdominal Pain (AP)Disorders of Gut-brain Interaction
Locations
Nationwide Children's Hospital
Columbus, Ohio 43205
United States