RECRUITING

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

Conditions

Sickle Cell Disease pain management in Sickle cell disease Trans-auricular vagal nerve stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07090668

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.

Ages Eligible for Study:7 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Anna Woodbury, MD

CONTACT

470-882-8960

awoodbu@emory.edu

Vipin Bansal, MD

CONTACT

404-630-9552

vbansa7@emory.edu

Principal Investigator

Anna Woodbury, MD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Children's Hospital of Atlanta: Eagelston

Atlanta, Georgia, 30329

United States

Collaborators and Investigators

Sponsor: Emory University

Anna Woodbury, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2026-07

Study Record Updates

Study Start Date2025-07

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

sickle cell disease
pain management in Sickle cell disease
Trans-auricular vagal nerve stimulation

Additional Relevant MeSH Terms

Sickle Cell Disease