Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
Emory University
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.
Description
The vagus nerve, the body's longest cranial nerve, extends from the brainstem to deep regions of the gastrointestinal tract and plays a vital role in regulating parasympathetic activity across multiple organ systems, including the cardiovascular, respiratory, immune, and nervous systems. Since the early 2000s, vagal nerve stimulation (VNS) has been explored as a therapeutic tool across various diseases, particularly for pain management. VNS can reduce pain by three primary mechanisms: 1) suppressing systemic inflammation, 2) modulating central pain-processing pathways, and 3) alleviating depre…
Eligibility
- Age range
- 7–18 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DevicetAN device
Sparrow Link tAN device from Spark Biomedical, a non-invasive, adhesive earpiece placed over branches of the trigeminal nerve and vagus nerve near the tragus and mastoid around the ear. The stimulation level is titrated by the investigator to a perceptible but comfortable intensity. Patients cannot adjust the settings themselves, though adjustments can be made upon request. The device consists of a disposable earpiece connected by a cable to a battery-powered controller (3 AAA batteries). It emits a biphasic, rectangular waveform with a 100 µs interphase and a maximum output of 95V.
Location
- Children's Hospital of Atlanta: EagelstonAtlanta, Georgia