Trans-auricular nerve stimulation for pain in children with sickle cell disease
Official title: Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
Run by Emory University · NCT07090668 · Data updated 2026-11-12
This trial will test whether gentle electrical stimulation of nerves at the outer ear can reduce pain in children with sickle cell disease who are hospitalized for pain crises.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 7 Years to 18 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | August 12, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07090668 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children with sickle cell anemia (HbSS) who have normal outer ear anatomy and are hospitalized for an SCD pain crisis are the intended participants.
✕Probably not a fit
Patients with a history of seizures, uncontrolled psychiatric illness, recurrent autonomic instability, cardiomyopathy, acute chest syndrome, recent surgery, hemodynamic instability, or pregnancy are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center interventional trial uses a trans-auricular nerve stimulation (tAN) device to deliver noninvasive stimulation targeting vagal and trigeminal ear branches in pediatric patients with HbSS experiencing sickle cell pain crises. The primary aim is feasibility, measured by completion rate, tolerability of stimulation, and participant acceptability. Secondary outcomes explore preliminary efficacy through inflammatory serum biomarkers, the Functional Status Scale, Wong-Baker FACES pain scores, and tracking analgesic consumption. The intervention is delivered during hospitalization at Children's Hospital of Atlanta: Eagelston and focuses on safety and early signals of clinical benefit in children.
Why it matters
Potential benefit: If successful, this approach could lower pain levels, reduce opioid use, and decrease inflammation in children with sickle cell disease.
How similar studies have gone: Vagal nerve stimulation has shown pain- and inflammation-reducing effects in adult and preclinical studies, but transauricular VNS specifically for pediatric sickle cell pain is novel and has limited direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of sickle-cell anemia (HbSS) * Normal outer ear anatomy and intact skin for tAN placement * Hospitalized for a pain crisis and experiencing pain as a result of SCD * Patients must have had at least one prior hospitalization for a sickle cell pain crisis in the past Exclusion Criteria: * History of seizures * History of uncontrolled psychiatric illness * Repeated episodes of autonomic instability (apnea or bradycardia) that are not self-resolving * Cardiomyopathy * Diagnosis of Acute Chest Syndrome * Unrepaired congenital anomalies affecting the cardiovascular or respiratory system * Hemodynamically unstable patients * Females who are pregnant or lactating. Subjects who refuse a pregnancy test. * Women of childbearing potential, not using adequate contraception as per the investigator's judgment, or not willing to comply with contraception for the duration of the study * Patients with a history of surgery within the last 3 months * Patients who suffered from a stroke within the last 3 months * Patient admitted with a fever or who develops a fever throughout their hospitalization * Patients whose disease-modifying therapy (HU, chronic transfusions, etc.) and/or pain medications (gabapentin, pregabalin, etc.) have not yet reached a steady dose * Patients who have had 3 or more hospitalizations for acute pain crises in a given year
Where it's running
-
Children's Hospital of Atlanta: Eagelston
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Anna Woodbury, MD — Emory University
- Study coordinator: Anna Woodbury, MD
- Email: awoodbu@emory.edu
- Phone: 470-882-8960
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.