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New treatment option for Sickle Cell Disease
Official title Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease
ClinicalTrials.gov ID: NCT07090668
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 18
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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. people 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.