NCT07090668Recruiting
Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 12 Aug 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Emory University
- Diseases
- Sickle cell disease
- NCT number
- NCT07090668
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 12 Aug 2025 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 7 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Atlanta: Eagelston Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.