160 Participants Needed

Auricular Vagus Nerve Stimulation for Stroke

(TAVERN Trial)

AH
RD
Overseen ByRaj Dhar, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

EL

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

Patient or authorized legal representative should be able to provide consent within 36 hours of ICU arrival
I am 18 years old or older.
I was admitted to the NeuroICU within 36 hours after my condition started.
See 1 more

Exclusion Criteria

Implanted electrical device (e.g., pacemaker, stimulator)
Bradycardia on admission (Sustained bradycardia on arrival with a heart rate < 50 bpm for >5 minutes)
Pregnancy
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive twice-daily auricular vagal nerve stimulation or sham stimulation

14 days
Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurological outcomes and discharge destination

Up to 1 year
Follow-up visits up to 1 year after discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Auricular Vagus Nerve Stimulation
  • Sham Auricular Vagus Nerve Stimulation
Trial Overview The study tests Auricular Vagus Nerve Stimulation (taVNS) against a sham procedure to see if it reduces complications, shortens hospital stays, and offers economic benefits in neurocritical care patients.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Auricular VNS StimulationExperimental Treatment1 Intervention
Group II: Sham Auricular VNS StimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38452937/
Transcutaneous auricular vagus nerve stimulation for post- ...Results: The concomitant application of ta-VNS demonstrated a remarkable reduction in HAMD-17 and SDS scores, leading to noteworthy enhancements ...
tVNS in Stroke: A Narrative Review on the Current State ...Transcutaneous vagus nerve stimulation (tVNS) has shown promising evidence as a tool to reduce infarct size in animal models of hyperacute stroke.
Review Vagus nerve stimulation in various stages of stroke ...This review highlights the mechanistic underpinnings and clinical outcomes of VNS across stroke phases, while also emphasizing the current ...
Efficacy and Safety of Vagus Nerve Stimulation on Upper ...VNS together with physical therapy increases upper limb motor recovery of stroke patients by an average of 7 points in the Fugl-Meyer scale, ...
Efficacy and safety of transcutaneous auricular vagus ...ta-VNS combined with conventional rehabilitation training greatly improved the recovery of motor and sensory functions and emotional responses.
Safety of transcutaneous auricular vagus nerve stimulation ...Although the general impression is that taVNS is a safe technique with only mild and transient adverse effects (AEs), human data on safety and ...
Efficacy and safety of transcutaneous auricular vagus ...There were no obvious side effects. These findings suggest that ta-VNS combined with conventional rehabilitation training for the treatment of acute ischemic or ...
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