Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial.
Anna L Huguenard, Gansheng Tan, Dennis J Rivet...
https://pubmed.ncbi.nlm.nih.gov/38746275Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06799390
Vagus Nerve Stimulation Following Intracerebral Hemorrhage to Reduce Inflammation and Cerebral Edema
Led by Washington University School of Medicine · Updated on 2025-07-15
80
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether non-invasive auricular vagal nerve stimulation (VNS) can reduce inflammation and improve outcomes in patients who have experienced an intracerebral hemorrhage (ICH). The study aims to see how this stimulation affects inflammatory markers in blood and cerebrospinal fluid, as well as its impact on clinical events and recovery following the hemorrhage. Participants are randomly assigned to receive either active auricular VNS twice daily or a sham stimulation where the device is placed without delivering current. Blood and cerebrospinal fluid samples will be collected at admission and throughout the hospital stay, which typically lasts about 14 days. The study monitors the growth of perihematomal edema, neurological worsening, and hospital length of stay during this period. After discharge, participants' functional outcomes will be assessed at follow-up visits for up to two years. The study does not require additional appointments specifically for research purposes. Researchers will track changes in inflammatory markers, neurological status, and recovery to understand the effects of auricular VNS on inflammation and cerebral edema after intracerebral hemorrhage.
CONDITIONS
Brief Title
Auricular VNS Following Intracerebral Hemorrhage
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital
You will not qualify if you...
- Patients under 18 years old
- Patients with traumatic cause of ICH, infratentorial location, ICH volume greater than 60 ml or less than 10 ml
- Patients at risk of imminent death (e.g., Glasgow Coma Scale of 3 or unreactive pupils)
- Patients with imminent surgical intervention planned (excluding ventriculostomy)
- Patients undergoing active cancer therapy
- Patients with sustained bradycardia (heart rate less than 50 beats per minute) on arrival
- Patients who cannot be enrolled within 48 hours of the initial bleed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - Up to 48 hours after the initial bleed
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Average 14 days during hospital admission
Participants receive twice daily auricular vagal nerve stimulation or sham stimulation during their hospital stay.
Twice daily stimulation sessions during hospital stay
Follow-up
Duration - Up to 2 years after discharge
Participants are monitored for neurological outcomes and functional scores at discharge and during follow-up visits for up to 2 years after discharge.
Follow-up visits aligned with routine clinical care; no additional visits specifically for the research study
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
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Research Team
R
Raj Dhar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial.
Anna Huguenard, Gansheng Tan, Gabrielle Johnson...
https://pubmed.ncbi.nlm.nih.gov/39178291The 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/39786346