Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04557618

Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage

Led by Anna Huguenard · Updated on 2025-12-26

50

Participants Needed

1

Research Sites

130 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 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

Brief Title

Auricular VNS Following Subarachnoid Hemorrhage

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with spontaneous subarachnoid hemorrhage
Not Eligible

You will not qualify if you...

  • Subarachnoid hemorrhage caused by trauma
  • Currently receiving chemotherapy
  • Taking immunosuppressive medications for other illnesses
  • Presence of a pacemaker device
  • Prolonged slow heart rate (bradycardia) at time of admission

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

Loading map...

Research Team

A

Anna L Huguenard, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Pilot Study of 3D Ultrasound Localization Microscopy to Dete...

Subarachnoid Hemorrhage

Actively Recruiting

1 location

Use of Active Fluid Exchange to Therapeutically Treat Intrac...

Intraventricular Hemorrhage

Actively Recruiting

1 location

Blood Pressure Treatment in ICU Patients with Subarachniodal...

Blood Pressure

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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/39786346

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/39178291

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

The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: a safety study.

Gansheng Tan, Anna L Huguenard, Kara M Donovan...

https://pubmed.ncbi.nlm.nih.gov/38633771

Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial.

Anna L Huguenard, Gansheng Tan, Gabrielle W Johnson...

https://pubmed.ncbi.nlm.nih.gov/38562875