Auricular Vagus Nerve Stimulation for Stroke
(TAVERN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether auricular vagus nerve stimulation (taVNS) can help patients in the NeuroICU recover more quickly from strokes or other serious brain conditions. Researchers aim to determine if this treatment reduces complications, shortens hospital stays, and lowers healthcare costs. Participants will receive either the actual stimulation or a sham (inactive) version for comparison. Suitable candidates have recently been admitted to the NeuroICU due to a severe brain condition, such as a stroke or brain injury, and require critical care, including mechanical ventilation or medication support. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could improve recovery outcomes for future patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that auricular vagus nerve stimulation is safe for stroke patients?
Research has shown that stimulating the ear's vagus nerve (taVNS) is generally safe. Studies have found it to be well-tolerated, with mostly mild and short-lasting side effects. For instance, one study found no noticeable side effects when taVNS was used alongside standard stroke recovery treatments. Another study suggested that taVNS is safe but highlighted the need for more information on its safety in humans. Overall, evidence suggests that taVNS is a low-risk treatment option.12345
Why are researchers excited about this trial?
Unlike traditional treatments for stroke that often rely on medications to dissolve clots or surgical interventions, Auricular Vagus Nerve Stimulation (VNS) takes a different approach. This treatment is unique because it targets the vagus nerve through the ear, which is thought to help in neuroplasticity and recovery after a stroke. Researchers are excited about this method because it offers a non-invasive and potentially faster way to enhance brain recovery, compared to conventional stroke therapies that primarily focus on restoring blood flow. By stimulating nerve pathways, this approach could open new doors for improving patient outcomes in stroke rehabilitation.
What evidence suggests that auricular vagus nerve stimulation is effective for stroke?
This trial will compare Auricular Vagus Nerve Stimulation (taVNS) with Sham Auricular Vagus Nerve Stimulation. Research has shown that stimulating the vagus nerve in the ear (taVNS) might aid stroke recovery. Studies have found that taVNS can reduce stroke size in animal tests. When combined with regular rehabilitation, taVNS has improved movement, sensation, and emotions in stroke patients. Specifically, one study found it could enhance arm and hand recovery by an average of 7 points on a common recovery scale. These findings suggest that taVNS could be a promising tool for aiding stroke recovery.12467
Who Is on the Research Team?
Eric Leuthardt, MD MBA
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for NeuroICU patients with conditions like gut-brain axis disorders, central nervous system issues, vascular problems, bleeding, or stroke. Specific eligibility details are not provided but typically include stable condition and no contraindications to the intervention.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive twice-daily auricular vagal nerve stimulation or sham stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including neurological outcomes and discharge destination
What Are the Treatments Tested in This Trial?
Interventions
- Auricular Vagus Nerve Stimulation
- Sham Auricular Vagus Nerve Stimulation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor