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RecruitingNCT07798180Updated Sep 1, 2026

Transauricular Neurostimulation for Abdominal Pain Due to DGBI

An interventional study of Transcutaneous auricular neurostimulation in Abdominal Pain (AP) and Disorders of Gut-brain Interaction, sponsored by Nationwide Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Oct 2025, registered Aug 2026).
  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
12 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 158 studies in Abdominal Pain with a site in United States — 23 open to participants now, 24 under way, 1 of them phase 3. Abdominal Pain · United States.

Planned enrollment
92nd of 133
30 · median 61
Started
2025
with 9 others
No phase
74 of 158
16 open now
Primary completion
2026-10
later than 3 of 23 live
Registered
156th of 158
by date

Among the 158 studies in Abdominal Pain with a site in United States, this one is the 92nd largest by planned enrollment of the 133 interventional ones that give a count, is one of 10 that started in 2025, is one of 74 with no phase, reaches primary completion later than 3 of the 23 other live ones, and was the 156th registered.

Abdominal Pain

387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 290 interventional studies indexed under Abdominal Pain.

Browse Abdominal Pain studies →

Open to participants now

23 of the 158 studies in Abdominal Pain with a site in United States are open now, in 1 country. Each count lists the studies.

All 23 open studies →

Who these studies take

Of the 33 Abdominal Pain studies recruiting now, 13 (39%) set no upper age limit and 17 (52%) stop at 75 or younger; 10 take children under 18; 7 take healthy volunteers.

This study: 12 Years to 18 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 158 studies in Abdominal Pain with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Abdominal Pain (AP)
  • Disorders of Gut-brain Interaction

Browse trials for

Keywords

  • transcutaneous auricular neurostimulation
  • neuromodulation
  • pediatric abdominal pain
  • DGBI
04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Transauricular neurostimulation

    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

  • DeviceTranscutaneous auricular neurostimulation

    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

06

What researchers measure

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 8

  2. 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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 35978394 ↗
  • 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. PubMed 42268178 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared. Aggregate study results will be published. Any external data sharing would require prior Nationwide Children's Hospital approval and appropriate agreements.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 12 months after the start.

Of 85 non-industry interventional studies with no phase under Abdominal Pain, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 30. This study's planned 12 months is below that.

Counting every sponsor, half of 101 studies reached it within 13 months; a quarter within 5 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Sep 1, 2026
StartActual
Oct 23, 2025
Primary completionEst.
Oct 30, 2026
CompletionEst.
Oct 30, 2026
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07798180
Responsible party
Peter Lu (Professor of Pediatrics, Nationwide Children's Hospital) — Principal investigator
First posted
Sep 1, 2026
Start date
Oct 23, 2025
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Sep 1, 2026

Study contacts

Peter Lu, MD
Contact
Peter.Lu@nationwidechildrens.org
(614) 722-3421
Eduardo Castillo Leon, MD
Contact
eduardo.castilloleon@nationwidechildrens.org
617-722-3874
Peter Lu, MD
principal investigator · Nationwide Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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