Auricular VNS Following Subarachnoid Hemorrhage

Anna Huguenard

Status: Enrolling

Conditions: Subarachnoid Hemorrhage

Treatments: Device: Auricular Vagus Nerve Stimulation; Device: Sham Auricular Vagus nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04557618

202007034

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spontaneous subarachnoid hemorrhage

Exclusion criteria

• Trauma-induced subarachnoid hemorrhage
• Ongoing chemotherapy
• Taking immunosuppressive medications for other medical illnesses
• Presence of a pacemaker
• Prolonged bradycardia at time of admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Auricular VNS Stimulation

Experimental group

Description:

Participants receive twice daily auricular vagal nerve stimulation

Treatment:

Device: Auricular Vagus Nerve Stimulation

Sham Auricular VNS Stimulation

Sham Comparator group

Description:

Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied

Treatment:

Device: Sham Auricular Vagus nerve Stimulation