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

NCT07090668 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

tAN 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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Anna Woodbury, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07090668 on ClinicalTrials.gov