What this study is
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.
What's being tested
- tAN device
Intervention · 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.
Study details
- Sponsor
- Emory University
- Conditions
- Sickle Cell Disease
- Enrolling
- 20 people
- Starts
- 2025-08-12
- Est. completion
- 2027-01
- Design
- Double-blind, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 7 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openChildren's Hospital of Atlanta: Eagelston
Atlanta, Georgia, United States
- Anna Woodbury, MD · Contact470-882-8960awoodbu@emory.edu
- Vipin Bansal, MD · Contact404-630-9552vbansa7@emory.edu
Recruiting
Study team
Sponsor
Emory University
Study ID STUDY00008398
Principal investigator
Anna Woodbury, MD
Emory University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.