Transauricular Neurostimulation for Abdominal Pain Due to DGBI

NCT07798180 | Recruiting FDA Device

• 2 other identifiers: STUDY00004247GR003143
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

transcutaneous auricular neurostimulation; neuromodulation; pediatric abdominal pain; DGBI

Outcome Measures

Primary Outcomes (2)

• Treatment Adherence Rate

  Description: Percentage of the 28 prescribed intervention days with recorded Sparrow Link device use, calculated from device logs.

  During the 4-week intervention period.

• Study completion rate

  Percentage of enrolled participants who complete the 8-week study.

  From enrollment through week 8.

Secondary Outcomes (4)

• Change in Pain Frequency, Severity, and Duration

  Baseline through week 8

• Change in Pediatric Quality of Life

  Baseline through week 8.

• Change in Anxiety

  Baseline through week 8.

• Change in Bristol Stool Form Scale

  Baseline through week 8.

Study Arms (1)

Transauricular neurostimulation

EXPERIMENTAL

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.

Device: Transcutaneous auricular neurostimulation

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.

Also known as: Sparrow Link

Transauricular neurostimulation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Related Publications (2)

• Tirado CF, Washburn SN, Covalin A, Hedenberg C, Vanderpool H, Benner C, Powell DP, McWade MA, Khodaparast N. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022 Aug 18;8(1):12. doi: 10.1186/s42234-022-00095-x.

  PMID: 35978394 BACKGROUND

• Peng X, Cox SS, Sutton F, Wood M, Tucker KB, Cash N, Badran BW, Borckardt JJ. Concurrent taVNS-fMRI Revealed Similar Brain Activation Patterns Elicited by Stimulation of the Mastoid and the Cymba Conchae. Neuromodulation. 2026 May 7:S1094-7159(26)00113-3. doi: 10.1016/j.neurom.2026.04.015. Online ahead of print.

  PMID: 42268178 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Peter Lu, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lu, MD

CONTACT

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

Eduardo Castillo Leon, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Single-group, open-label pilot treatment study. All participants receive active transcutaneous auricular neurostimulation using the Sparrow Link device for at least one hour daily for 4 weeks. There is no randomization or control group.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 1, 2026
• Study Start: October 23, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)