Abdominal Pain (AP)NCT07798180
Transauricular Neurostimulation for Abdominal Pain Due to DGBI
A study testing Transcutaneous auricular neurostimulation in people with Abdominal Pain (AP) and Disorders of Gut-brain Interaction, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Abdominal Pain (AP), Disorders of Gut-brain Interaction
- What is being tested?
- Transcutaneous auricular neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Peter Lu, MD, (614) 722-3421, Peter.Lu@nationwidechildrens.org
About this study
Official title: Transauricular Neurostimulation for Irritable Bowel Syndrome
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.
- Being tested
- Transcutaneous auricular neurostimulation
- Keywords
- transcutaneous auricular neurostimulation, neuromodulation, pediatric abdominal pain, DGBI
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular neurostimulationDevice
Also called Sparrow Link
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.
| Study group | Role | What they receive |
|---|---|---|
| Transauricular neurostimulation | Experimental | 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. Receives: Device: Transcutaneous auricular neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence Rate
Description: Percentage of the 28 prescribed intervention days with recorded Sparrow Link device use, calculated from device logs.
Measured: During the 4-week intervention period.
Study completion rate
Percentage of enrolled participants who complete the 8-week study.
Measured: From enrollment through week 8.
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline through week 8.
Change in Anxiety
Change in the State-Trait Anxiety Inventory for Children score; higher scores indicate greater anxiety.
Measured: Baseline through week 8.
Change in Bristol Stool Form Scale
Average stool form over the previous week, rated from Type 1 to Type 7.
Measured: Baseline through week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start23 Oct 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abdominal Pain (AP)Studies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lu, Nationwide Children's Hospital
- Investigators
- Peter Lu, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798180
- Sponsor's protocol ID
- STUDY00004247
- Other IDs
- GR003143
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
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 35978394Peng 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transauricular Neurostimulation for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07798180
- Acronym / sponsor ID
- STUDY00004247
- Keywords
- transcutaneous auricular neurostimulation, neuromodulation, pediatric abdominal pain, DGBI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transauricular neurostimulation | Experimental | Device: Transcutaneous auricular neurostimulationAll 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous auricular neurostimulationAlso: Sparrow LinkParticipants 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. | Device | Transauricular neurostimulation |
Primary outcome
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.
Study completion rate
Time frame: From enrollment through week 8.
Percentage of enrolled participants who complete the 8-week study.
4 secondary outcomes
Change in Pain Frequency, Severity, and Duration
Time frame: Baseline through week 8
Change in Pediatric Quality of Life
Time frame: Baseline through week 8.
Change in Anxiety
Time frame: Baseline through week 8.
Change in Bristol Stool Form Scale
Time frame: Baseline through week 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 35978394Tirado 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.
- Background: PubMed 42268178Peng 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Lu, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular neurostimulation in people with Abdominal Pain (AP) and Disorders of Gut-brain Interaction, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Lu, MD ((614) 722-3421, Peter.Lu@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence Rate (time frame: During the 4-week intervention period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07798180, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.