NCT07090668 Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
| NCT ID | NCT07090668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-08-12 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Anna Woodbury, MD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT07090668 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 18 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07090668 currently recruiting?
Yes, NCT07090668 is actively recruiting participants. Contact the research team at awoodbu@emory.edu for enrollment information.
Where is the NCT07090668 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT07090668 clinical trial?
NCT07090668 is sponsored by Emory University. The principal investigator is Anna Woodbury, MD at Emory University. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.