Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07090668
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • tAN device — 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

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.

Key Dates

Start date
Aug 12, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Controls (Same participant but past data)
    Participants will serve as their own controls. Using chart review, we will collect data from each participant's previous admission for a pain crisis during which they did not receive tAN treatment and compare it to their current admission, during which they are being treated with tAN
  • Experimental: tAN group
    Subjects admitted to CHOA with SCD pain crisis.

Primary Outcome Measure

Feasibility: Completion Rate [ Time Frame: Through study completion (an average of 3-7 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of Atlanta: EagelstonAtlantaGeorgia30329
Anna Woodbury, MD
[email protected]
470-882-8960
Vipin Bansal, MD
[email protected]
404-630-9552

Find similar trials in Atlanta, GA

By condition
Sickle cell disease
By research site
Children's Hospital of Atlanta: Eagelston· Atlanta, GA

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