Testing an ear nerve stimulation device for pain in children with sickle cell disease
Tests an ear nerve stimulation device for pain in children with sickle cell disease.
Plain-language title generated from the registry record
Registry title: Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
Key facts
- Where
- Atlanta, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 18 years old?
Source: NCT07090668, who can take part
Where in United States
- Children's Hospital of Atlanta: EagelstonAtlanta, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Emory University
- Trial code
- NCT07090668
- Record updated
- 22 October 2026
- Original description
The goal of this study is to evaluate the effects of transauricular vagus and trigeminal nerve stimulation on the treatment of pain in children with Sickle Cell Disease.Read full original descriptionShow less
Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
The goal of this study is to evaluate the effects of transauricular vagus and trigeminal nerve stimulation on the treatment of pain in children with Sickle Cell Disease.
* The primary objective is to determine the feasibility of using a tAN device to treat pain in pediatric participants with SCD by assessing the completion rate, stimulation tolerability, and acceptability of the intervention measures. * The secondary objective is to assess the preliminary efficacy of using a tAN device as a remedy for pain in pediatric SCD subjects by analyzing inflammatory serum biomarker levels, the Functional Status Scale (FSS), the Wong-Baker FACES questionnaire, tracking analgesic consumption, and other assessments.
Inclusion: 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: History of seizures; History of uncontrolled psychiatric illness; Diagnosis of Acute Chest Syndrome; Patients with a history of surgery within the last 3 months; Patients who suffered from a stroke within the last 3 months; Patients whose disease-modifying therapy (HU, chronic transfusions, etc.) and/or pain medications (gabapentin, pregabalin, etc.) have not yet reached a steady dose; Repeated episodes of autonomic instability (apnea or bradycardia) that are not self-resolving; Cardiomyopathy; 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; Patient admitted with a fever or who develops a fever throughout their hospitalization; Patients who have had 3 or more hospitalizations for acute pain crises in a given year.