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Transauricular Neurostimulation for Abdominal Pain Due to DGBI
Sponsor: Nationwide Children's Hospital
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.
Official title: Transauricular Neurostimulation for Irritable Bowel Syndrome
Key Details
Gender
All
Age Range
12 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-10-23
Completion Date
2026-10-30
Last Updated
2026-09-01
Healthy Volunteers
No
Interventions
Transcutaneous auricular neurostimulation
Participants will use the wearable Sparrow Link device for at least one hour daily for 4 weeks. Self-adhesive electrodes placed on and around the ear deliver noninvasive electrical stimulation. Region 1 uses 30 Hz with a 500-microsecond pulse width, and Region 2 uses 100 Hz with a 250-microsecond pulse width. The duty cycle is 5 minutes on and 10 seconds off. Amplitude ranges from 0 to 5.0 mA and is adjusted to a comfortable level.
Locations (1)
Nationwide Children's Hospital
Columbus, Ohio, United States