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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
7 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a device that stimulates nerves through the outer ear to help treat pain in children with sickle cell disease. It checks whether children can complete the treatment, tolerate it, and find it acceptable. It also looks for early signs that the treatment helps with pain.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have sickle cell anemia of the HbSS type.
  • Have a normally shaped outer ear with unbroken skin where the device will go.
  • Be in the hospital for a sickle cell pain crisis and have pain from the disease.
  • Have had at least one past hospital stay for a sickle cell pain crisis.

Who can't join

  • Have a history of seizures or mental illness that is not under control.
  • Have repeated pauses in breathing or a slow heartbeat that do not get better on their own.
  • Have heart muscle disease, acute chest syndrome (a serious lung problem), or an unrepaired birth defect affecting the heart, blood vessels, or breathing system.
  • Have unstable blood pressure or blood flow, or have a fever when admitted or during the hospital stay.
  • Are pregnant or breastfeeding, refuse a pregnancy test, or could become pregnant but are not using birth control the study doctor accepts or will not use it throughout the study.
  • Have had surgery or a stroke within the past 3 months.
  • Are taking sickle cell treatments or pain medicines whose doses are not yet steady.
  • Have had 3 or more hospital stays for sudden pain crises in a given year.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

GA