RecruitingNot ApplicableNCT07798180

Transauricular Neurostimulation for Abdominal Pain Due to DGBI

Transauricular Neurostimulation for Irritable Bowel Syndrome

Sponsor

Nationwide Children's Hospital

Enrollment

30 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Disorders of Gut-Brain Interaction Abdominal Pain (AP)

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

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Transcutaneous auricular neurostimulation for people with abdominal pain (ap) and disorders of gut-brain interaction. The study is currently recruiting participants at 1 location. People eligible for this study include aged 12 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous 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.