Actively Recruiting
Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
Led by Emory University · Updated on 2026-01-26
20
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of sickle-cell anemia (HbSS)
- Normal outer ear anatomy and intact skin suitable for tAN device placement
- Hospitalized for a pain crisis caused by sickle cell disease
- At least one prior hospitalization for a sickle cell pain crisis
You will not qualify if you...
- History of seizures
- History of uncontrolled psychiatric illness
- Repeated episodes of unresolved autonomic instability (apnea or bradycardia)
- Cardiomyopathy
- Diagnosis of Acute Chest Syndrome
- Unrepaired congenital anomalies affecting cardiovascular or respiratory systems
- Hemodynamically unstable patients
- Females who are pregnant, lactating, or refuse pregnancy testing
- Women of childbearing potential not using adequate contraception or unwilling to comply
- Surgery within the last 3 months
- Stroke within the last 3 months
- Admission with fever or fever developing during hospitalization
- Disease-modifying therapy or pain medications not at steady dose
- Three or more hospitalizations for acute pain crises in a year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Atlanta: Eagelston
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
A
Anna Woodbury, MD
CONTACT
V
Vipin Bansal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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