Transauricular Neurostimulation for Abdominal Pain Due to DGBI

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT07798180
Status
Recruiting
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Conditions

  • Abdominal Pain (AP)
  • Disorders of Gut-brain Interaction

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous auricular neurostimulation — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Oct 23, 2025
Status verified
Aug 2026
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Transauricular neurostimulation
    All participants receive active transcutaneous auricular neurostimulation using the Sparrow Link device for at least one hour daily for 4 weeks, with follow-up assessments through week 8.

Primary Outcome Measure

Treatment Adherence Rate [ Time Frame: During the 4-week intervention period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Peter Lu, MD
[email protected]
(614) 722-3421

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By research site
Nationwide Children's Hospital· Columbus, OH

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