Transauricular Neurostimulation for Abdominal Pain Due to DGBI

Nationwide Children's Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abdominal Pain (AP)Disorders of Gut-brain Interaction

Interventions

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Treatment Adherence Rate

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

Time frame: During the 4-week intervention period.

Study completion rate

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

Time frame: From enrollment through week 8.

Secondary Outcomes

Change in Pain Frequency, Severity, and Duration

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.

Time frame: Baseline through week 8

Change in Pediatric Quality of Life

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

Time frame: Baseline through week 8.

Change in Anxiety

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

Time frame: Baseline through week 8.

Change in Bristol Stool Form Scale

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

Time frame: Baseline through week 8.

Transauricular Neurostimulation for Abdominal Pain Due to DGBI

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts