NCT04557618

Auricular VNS Following Subarachnoid Hemorrhage

Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Anna Huguenard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.

Detailed description

Vagal nerve stimulation (VNS) has been studied in several inflammatory conditions, and has been implemented in animal models of subarachnoid hemorrhage (SAH) with promising results. The purpose of the proposed study is to determine how applying auricular VNS in patients presenting with spontaneous SAH impacts their expression of inflammatory markers in their blood and cerebrospinal fluid (CSF), and how it impacts their clinical course and outcomes. This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood and CSF will be collected on admission, and serially throughout the patient's admission. Clinical events tracked during the hospital stay include development of cerebral vasospasm, need for CSF diversion via a shunt, stress-induced cardiomyopathy, and development of stroke or global cerebral ischemia. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge.

Conditions

• Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DEVICE	Auricular Vagus Nerve Stimulation	Transcutaneous auricular vagal nerve stimulation
DEVICE	Sham Auricular Vagus nerve Stimulation	Transcutaneous auricular vagal nerve ear clip applied without current

Timeline

• Start date: 2021-01-05
• Primary completion: 2026-06-01
• Completion: 2028-12-01
• First posted: 2020-09-21
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States