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/38746275/Actively Recruiting
Led by Washington University School of Medicine · Updated on 2026-07-06
80
Participants Needed
1
Research Sites
104 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 an intracerebral hemorrhage. This study focuses on the effects of transcutaneous auricular VNS on inflammation in the blood and cerebrospinal fluid, as well as on the clinical progression and recovery of patients with spontaneous supratentorial intracerebral hemorrhage. Participants will be randomly assigned to either receive twice daily auricular VNS stimulation or a sham stimulation using an ear clip without current. Blood and cerebrospinal fluid samples will be collected upon admission and at multiple points during the hospital stay. Clinical events such as peri-hematomal edema development, treatments for edema, and length of ICU and hospital stays will be tracked. Functional outcomes will be measured at discharge and during follow-up visits for up to two years, with no extra visits required solely for the study. During the study, participants will undergo regular clinical monitoring, blood and cerebrospinal fluid testing, and evaluation of neurological status. Researchers will measure changes in inflammatory markers like IL-6, growth of perihematomal edema, neurological worsening during hospital admission, and long-term neurological outcomes. Hospital stay length will also be recorded. The total observation period extends up to two years following discharge, allowing assessment of both short-term and long-term effects.
CONDITIONS
Auricular VNS Following Intracerebral Hemorrhage
R
Raj Dhar, MD
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Washington University School of Medicine
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Auricular VNS (active device) | Sham auricular VNS (control) | Standard acute ICH care (bundle) |
|---|---|---|---|
| What it is | A device delivering non‑invasive auricular vagus nerve stimulation | A sham device applied to the ear without electrical stimulation | Supportive acute ICH care including blood pressure control, anticoagulation reversal, and coordinated neurocritical support |
| Role in trial | Tested investigational intervention | Control comparator indistinguishable from active device | Usual acute ICH management not part of randomization |
| Primary use | Explored for reducing inflammation and oedema after ICH | Used as an inactive control to assess device effect | To stabilize ICH patients by reducing hematoma expansion and managing acute threats |
| How it is given or performed | Applied transcutaneously to the ear to stimulate vagus nerve | Same ear clip applied without electrical current | Includes medical therapies such as medications, monitoring, and potentially surgery guided by clinical protocols |
| Evidence status | Effect under investigation; no results available yet | Used to assess active device effect; efficacy unknown | Supported by guideline-recommended bundle shown to reduce hematoma growth and improve outcomes |
| Important limitations | No results yet; unknown whether reducing IL‑6 or edema improves neurological outcomes | Control without stimulation; cannot inform treatment effectiveness alone | Optimal implementation depends on rapid diagnosis, protocol‑based care, and access to specialized units |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 baseline visit
Duration - Up to 14 days during hospital admission
Participants receive either auricular vagal nerve stimulation twice daily or sham stimulation without current while hospitalized. Blood and cerebrospinal fluid samples are collected to measure inflammatory markers, and clinical events are monitored.
Multiple assessments during hospital stay
Duration - Up to 2 years
Participants are monitored for neurological outcomes and functional status at discharge and during follow-up visits for up to two years after hospital discharge.
Periodic follow-up visits
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Anna L Huguenard, Gansheng Tan, Dennis J Rivet...
https://pubmed.ncbi.nlm.nih.gov/38746275/Anna Huguenard, Gansheng Tan, Gabrielle Johnson...
https://pubmed.ncbi.nlm.nih.gov/39178291/Gansheng Tan, Anna L Huguenard, Kara M Donovan...
https://pubmed.ncbi.nlm.nih.gov/39786346/Washington University School of Medicine
Lead Sponsor