Abdominal Pain (AP), Disorders of Gut-brain Interaction
Conditions
Keywords
transcutaneous auricular neurostimulation, neuromodulation, pediatric abdominal pain, DGBI
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.
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.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Adherence Rate | During the 4-week intervention period. | Description: Percentage of the 28 prescribed intervention days with recorded Sparrow Link device use, calculated from device logs. |
| Study completion rate | From enrollment through week 8. | Percentage of enrolled participants who complete the 8-week study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Frequency, Severity, and Duration | 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. |
| Change in Pediatric Quality of Life | Baseline through week 8. | Change in Pediatric Quality of Life Inventory score; higher scores indicate better quality of life. |
| Change in Anxiety | Baseline through week 8. | Change in the State-Trait Anxiety Inventory for Children score; higher scores indicate greater anxiety. |
| Change in Bristol Stool Form Scale | Baseline through week 8. | Average stool form over the previous week, rated from Type 1 to Type 7. |
Countries
United States
Contacts
CONTACTPeter Lu, MD
CONTACTEduardo Castillo Leon, MD
PRINCIPAL_INVESTIGATORPeter Lu, MD
Nationwide Children's Hospital
Outcome results
None listed