The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial.
Gansheng Tan, Anna L Huguenard, Kara M Donovan...
https://pubmed.ncbi.nlm.nih.gov/39786346Actively Recruiting
Led by Anna Huguenard · Updated on 2025-12-26
50
Participants Needed
1
Research Sites
130 weeks
Total Duration
Researchers are evaluating whether non-invasive auricular vagal nerve stimulation (VNS) can reduce inflammatory markers and improve outcomes in patients who have experienced spontaneous subarachnoid hemorrhage (SAH). This study aims to understand how auricular VNS affects inflammation in the blood and cerebrospinal fluid, as well as its impact on clinical events like cerebral vasospasm and stroke during hospital stay. The study also follows participants' functional recovery for up to two years after discharge. Participants are randomly assigned to one of two groups: one receiving auricular VNS twice daily using a device that stimulates the vagus nerve through the ear, and the other receiving a sham stimulation where the device is applied without active stimulation. Blood and cerebrospinal fluid samples are collected on admission and repeatedly during the hospital stay, which lasts about four weeks on average. Clinical events such as the need for cerebrospinal fluid shunting and stress-induced cardiomyopathy are monitored. Throughout the study, researchers assess inflammatory markers in serum and cerebrospinal fluid on admission and over the hospital stay. They track cerebral vasospasm, hydrocephalus, cerebral ischemia, and heart complications during hospitalization. Functional outcomes are evaluated at discharge and during follow-up visits extending up to two years. This thorough monitoring helps understand the safety and potential effects of auricular VNS for patients recovering from spontaneous SAH.
CONDITIONS
Auricular VNS Following Subarachnoid Hemorrhage
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks (hospital admission duration)
Participants receive twice daily auricular vagus nerve stimulation or sham stimulation during their hospital stay.
Daily visits during hospital stay
Duration - Up to 2 years after discharge
Participants are followed for clinical outcomes and functional scores after discharge for up to 2 years.
Follow-up visits for assessments up to 2 years
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
A
Anna L Huguenard, MD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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