Not a traditional drug phase: Transcutaneous auricular neurostimulation for Abdominal Pain (AP)
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 you would be enrolled, with a goal of 20 completing the study.
Official registry: https://clinicaltrials.gov/study/NCT07798180 · Nationwide Children's Hospital · enrollment listed as 30
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Transcutaneous auricular neurostimulation. The registry lists allocation as na. 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.
They plan to enroll about 30 people at Columbus. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Transauricular Neurostimulation for Irritable Bowel Syndrome
Interventions: Transcutaneous auricular neurostimulation
Primary outcome (registry wording): Treatment Adherence Rate
Who it is for (from inclusion criteria)
- Ages 12 Years to 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
Who the registry excludes
- 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 treatment trial
- Unable to communicate in English
- 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
Public study contact (from the registry)
Peter Lu, MD
Peter.Lu@nationwidechildrens.org
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Nationwide Children's Hospital — Columbus, Ohio (recruiting)
FAQ about this NCT record
Is NCT07798180 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07798180?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07798180?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary