Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
Recruiting · NCT07090668 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Children's Hospital of Atlanta: Eagelston - Atlanta, Georgia, United States