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

NCT07090668 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00008398
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Sickle Cell Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Feasibility: Completion Rate

  Completion rate will be calculated by dividing the number of subjects who successfully used tAN for the duration of the trial, divided by the total number of subjects who participated in the trial. Subjects who prematurely opt to interrupt their participation in the study will not be included in the cohort of patients who successfully completed the study

  Through study completion (an average of 3-7 days)

• Stimulation tolerability

  Stimulation tolerability will be evaluated daily during hospitalization by asking participants to describe any sensations experienced in response to percutaneous stimulation. Participants will be encouraged to express the sensation in their own words. The investigator will then further clarify the nature of the sensation-such as whether it feels like burning, tingling, or stabbing-to better characterize the participant's experience.

  Baseline, everyday throughout the study (an average of 3-7 days)

• Acceptability of intervention

  Acceptability of intervention measure will be assessed using a standardized 4 item questionnaire.

  Baseline, everyday throughout the study (an average of 3-7 days)

Secondary Outcomes (5)

• Wong-Baker FACES

  Baseline, everyday throughout the study (an average of 3-7 days)

• Functional Status Scale(FSS)

  Baseline, everyday throughout the study (an average of 3-7 days)

• Change in Interleukin 6 (IL-6) levels

  Baseline, end of the study (an average of 3-7 days)

• Change in MCP-1

  Baseline, end of the study (an average of 3-7 days)

• Change in Tumor necrosis factor (TNF-α)

  Baseline, end of the study (an average of 3-7 days)

Study Arms (2)

Controls (Same participant but past data)

NO INTERVENTION

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

tAN group

EXPERIMENTAL

Subjects admitted to CHOA with SCD pain crisis.

Device: tAN device

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.

tAN group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You 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 may not qualify 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Children's Hospital of Atlanta: Eagelston

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anna Woodbury, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Woodbury, MD

CONTACT

470-882-8960; awoodbu@emory.edu

Vipin Bansal, MD

CONTACT

404-630-9552; vbansa7@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Controlled, single blind feasibility study. Controls will be historical controls, consisting of patients with similar clinical presentations who did not receive tAN

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)