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NCT Number: NCT07798180

Transauricular Neurostimulation for Abdominal Pain Due to DGBI

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.

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Key information

Conditions

Abdominal Pain (AP) Abdominal Pain Disorders of Gut-brain Interaction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location status: Recruiting

Location contact

Peter Lu, MD

CONTACT

[email protected]

(614) 722-3421

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Sparrow Link

Primary outcomes

  1. Treatment Adherence Rate

    Time frame: During the 4-week intervention period.

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

  2. Study completion rate

    Time frame: From enrollment through week 8.

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

Secondary outcomes

  1. Change in Pain Frequency, Severity, and Duration

    Time frame: Baseline through week 8

    Pain Frequency-Severity-Duration Scale measures pain frequency from 0-7 days per week, usual and worst pain from 0-10, and pain duration. Higher pain scores indicate worse symptoms.

  2. Change in Pediatric Quality of Life

    Time frame: Baseline through week 8.

    Change in Pediatric Quality of Life Inventory score; higher scores indicate better quality of life.

  3. Change in Anxiety

    Time frame: Baseline through week 8.

    Change in the State-Trait Anxiety Inventory for Children score; higher scores indicate greater anxiety.

  4. Change in Bristol Stool Form Scale

    Time frame: Baseline through week 8.

    Average stool form over the previous week, rated from Type 1 to Type 7.

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Castillo Leon, MD

CONTACT

[email protected]

617-722-3874

Peter Lu, MD

CONTACT

[email protected]

(614) 722-3421

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Official study title

Transauricular Neurostimulation for Irritable Bowel Syndrome

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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