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

Description

The goal of this study is to evaluate the effects of transauricular vagal nerve stimulation on the treatment of pain in children with Sickle Cell Disease. * The primary objective is to determine the feasibility of using a taVNS 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 taVNS 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

Sickle Cell Disease
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Related Conditions:

Sickle Cell Disease

Study Overview

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Study Details

Study overview

The goal of this study is to evaluate the effects of transauricular vagal nerve stimulation on the treatment of pain in children with Sickle Cell Disease. * The primary objective is to determine the feasibility of using a taVNS 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 taVNS 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.

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

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

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Atlanta

Children's Hospital of Atlanta: Eagelston, Atlanta, Georgia, United States, 30329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of sickle-cell anemia (HbSS)
  • * Normal outer ear anatomy and intact skin for taVNS 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
  • * 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

Ages Eligible for Study

7 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Anna Woodbury, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2026-07