Recruiting

taVNS

Sponsor:

Emory University

Code:

NCT07090668

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Interventions

tAN device

Study Details

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

Study ID

NCT07090668

Start date

Aug 12, 2025

Status verified date

Jan, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • Feasibility: Completion Rate [ Time Frame: Through study completion (an average of 3-7 days) ]
  • Stimulation tolerability [ Time Frame: Baseline, everyday throughout the study (an average of 3-7 days) ]
  • Acceptability of intervention [ Time Frame: Baseline, everyday throughout the study (an average of 3-7 days) ]

Central Contacts and Locations

Central contacts

Anna Woodbury, MD

470-882-8960awoodbu@emory.edu

Vipin Bansal, MD

404-630-9552vbansa7@emory.edu

Locations

Children's Hospital of Atlanta: Eagelston

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Anna Woodbury, MD

470-882-8960awoodbu@emory.edu

Vipin Bansal, MD

404-630-9552vbansa7@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-26.