Transauricular Neurostimulation for Abdominal Pain Due to DGBI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorNationwide Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Transcutaneous auricular neurostimulation
DeviceParticipants 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Transauricular neurostimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.2
Study completion rate
Percentage of enrolled participants who complete the 8-week study.
Time frame
From enrollment through week 8.Secondary outcomes
1
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 82
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 8.3
Change in Anxiety
Change in the State-Trait Anxiety Inventory for Children score; higher scores indicate greater anxiety.
Time frame
Baseline through week 8.4
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.Sponsors and contacts
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Source ClinicalTrials.gov