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 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
A
Anna L Huguenard, MD
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Anna Huguenard
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 Stimulation | Sham VNS Stimulation |
|---|---|---|
| What it is | Device-based neuromodulation using electrical stimulation of the auricular branch of the vagus nerve through an ear clip. Intended as a non-invasive intervention. | Ear clip device applied in the same manner as the active group, but no electrical current is delivered. Serves as a placebo control for blinding and control of non-specific effects. |
| Role in the trial | Active treatment arm. Participants receive auricular VNS as the investigational therapy. | Comparator arm. Participants receive sham stimulation without current as the control intervention. |
| Primary use/purpose | To assess whether transcutaneous auricular VNS can reduce neuroinflammation and secondary neurologic complications, such as vasospasm and hydrocephalus, following spontaneous subarachnoid hemorrhage. | To serve as a placebo comparator, isolating the effects of device stimulation from non-specific device-related influences or patient expectations. |
| How it is given/performed | Device clips to the ear and delivers electrical pulses to the auricular branch of the vagus nerve. The protocol specifies stimulation in the hospital after admission for hemorrhage. | The same type of ear clip device is applied to the participant, but electrical current is not delivered. Procedures otherwise identical to those in the active arm. |
| Evidence status | Prior small randomized trials and early clinical studies, including NAVSaH and other published trials, suggest that auricular VNS may lower inflammation markers and reduce risk of vasospasm after subarachnoid hemorrhage, but larger studies are ongoing and longer-term clinical benefit is not yet established. | The sham device group serves as a baseline for comparison and does not provide therapeutic reduction of inflammation or vasospasm beyond placebo or usual care expectations. |
| Important limitations | Current evidence is based on small, early-phase trials; definitive patient outcome benefit, optimal stimulation protocol, and long-term safety after subarachnoid hemorrhage remain to be determined. | The sham protocol effectively blinding, but participants in this group do not receive active treatment and their outcomes reflect only non-specific effects and underlying disease progression. |
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 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
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor