Vagal Nerve Stimulation for Sickle Cell Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the effectiveness of a special device that stimulates the vagal nerve through the ear (trans-auricular vagal nerve stimulation) in reducing pain for children with Sickle Cell Disease (SCD). Participants will compare their experience using this device during a pain crisis to previous crises without it. Children with SCD who have been hospitalized for pain before and are currently admitted for a pain crisis might be suitable candidates. As an unphased trial, this study offers a unique opportunity for children to potentially experience pain relief through innovative technology.
Will I have to stop taking my current medications?
The trial requires that your current disease-modifying therapy and pain medications have reached a steady dose, so you may need to adjust your medications to meet this requirement.
What prior data suggests that this device is safe for treating pain in children with Sickle Cell Disease?
Research has shown that trans-auricular vagal nerve stimulation (taVNS) is generally safe. Studies have found that people usually tolerate taVNS well, experiencing few or no side effects. If side effects occur, they are typically mild and short-lived. This makes taVNS a promising and safe option for treating pain in conditions like sickle cell disease.12345
Why are researchers excited about this trial?
Researchers are excited about trans-auricular vagal nerve stimulation (taVNS) for sickle cell disease because it offers a novel approach to managing pain crises. Unlike standard treatments that often rely on pain medication like opioids, taVNS targets the nervous system directly by stimulating the vagus nerve through the ear. This method is non-invasive and may help reduce pain and inflammation without the side effects associated with traditional pain medications. The hope is that taVNS could provide faster relief and improve the quality of life for individuals with sickle cell disease.
What evidence suggests that trans-auricular vagal nerve stimulation is effective for treating pain in Sickle Cell Disease?
Research has shown that trans-auricular vagal nerve stimulation (taVNS) might help manage pain in people with Sickle Cell Disease (SCD). This technique stimulates a nerve in the ear, potentially reducing pain by altering how the body processes pain signals. Early studies suggest that taVNS might also decrease inflammation, often linked to pain. Research indicates that most people find this method comfortable and easy to use. Although more studies are needed, initial results are promising for using taVNS as a new way to manage pain in SCD. Participants in this trial will receive taVNS treatment and will be compared to their own past data when they did not receive taVNS, serving as their own controls.13456
Who Is on the Research Team?
Anna Woodbury, MD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for children with sickle cell anemia who are currently hospitalized due to a pain crisis. They must have had at least one previous hospitalization for such a crisis and should have normal ear anatomy where the taVNS device will be placed.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transauricular vagal nerve stimulation (taVNS) for pain management during hospitalization
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Trans-auricular Vagal Nerve Stimulation
Trial Overview
The study tests if trans-auricular vagal nerve stimulation (taVNS) can help manage pain in pediatric patients with Sickle Cell Disease. It looks at how well kids tolerate this treatment, its acceptability, and early signs of effectiveness through various health measures.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects admitted to CHOA with SCD pain crisis.
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 taVNS treatment and compare it to their current admission, during which they are being treated with taVNS
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Citations
Trans-auricular Vagal Nerve Stimulation as an Innovative ...
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.
Vagal Nerve Stimulation for Sickle Cell Disease
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.
Trans-auricular Vagal Nerve Stimulation as an Innovative ...
The goal of this study is to evaluate the effects of transauricular vagal nerve stimulation on the treatment of pain in children with Sickle ...
Transcutaneous Auricular Vagus Nerve Stimulation as ...
The goals of this randomized clinical trial are to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) combined with standard ...
Feasibility and effectiveness of transcutaneous auricular ...
We found that repetitive taVNS was well tolerated by awake mice, had no effect on anxiety‐like behaviors, and significantly improved memory.
Safety of transcutaneous auricular vagus nerve stimulation ...
Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet ...
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