Recruiting

Transcutaneous Auricular Neurostimulation

Sponsor:

Nationwide Children's Hospital

Code:

NCT07798180

Conditions

Abdominal Pain (AP)

Disorders of Gut-brain Interaction

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Transcutaneous auricular neurostimulation

Study Details

Brief 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.

Conditions

Abdominal Pain (AP)

Disorders of Gut-brain Interaction

Study ID

NCT07798180

Start date

Oct 23, 2025

Status verified date

Aug, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Treatment Adherence Rate [ Time Frame: During the 4-week intervention period. ]
  • Study completion rate [ Time Frame: From enrollment through week 8. ]

Central Contacts and Locations

Central contacts

Peter Lu, MD

(614) 722-3421Peter.Lu@nationwidechildrens.org

Eduardo Castillo Leon, MD

617-722-3874eduardo.castilloleon@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Peter Lu, MD

(614) 722-3421Peter.Lu@nationwidechildrens.org

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • transcutaneous auricular neurostimulation
  • neuromodulation
  • pediatric abdominal pain
  • DGBI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2026-09-01.