Auricular VNS Following Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557618
• Other study ID #: 202007034
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2021
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: Anna L Huguenard, MD
• Phone: 3144506698
• Email: ahuguenard[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• Auricular Vagus Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation
• Sham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve ear clip applied without current

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Anna Huguenard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers in the serum on admission	IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, TNF alpha from blood draws	On hospital day 1
Primary	Change in inflammatory markers in the serum	IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, TNF alpha from blood draws	Through hospital admission, average of 4 weeks
Primary	Inflammatory markers in the CSF on admission	IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, TNF alpha from cerebrospinal fluid	On hospital day 1
Primary	Change in inflammatory markers in the CSF on admission	IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, TNF alpha from cerebrospinal fluid	Through hospital admission, average of 4 weeks
Secondary	Cerebral vasospasm	Presence of vasospasm based on any of the following criteria: 1) Radiographic evidence of vasospasm on CT angiogram or catheter angiogram, 2) Need for blood pressure augmentation or hypervolemia, 3) Need for intraarterial or intrathecal vasodilator, 4) Need for angioplasty	Through hospital admission, average of 4 weeks
Secondary	Hydrocephalus	Presence of hydrocephalus based on any of the following criteria: 1) Need for temporary CSF diversion via an external ventricular drain, 2) Need for permanent CSF diversion via a ventricular shunt	Through hospital admission, average of 4 weeks
Secondary	Stressed-induced cardiomyopathy	Presence of stressed-induced cardiomyopathy based on any of the following criteria: 1) New troponin elevation, 2) New EKG changes (specifically ST segment elevation, ST segment depression, left bundle branch block, prolonged QT interval), 3) New findings of cardiomyopathy on echocardiogram	Through hospital admission, average of 4 weeks
Secondary	Cerebral ischemia	Presence of cerebral ischemia based on the following criteria: Radiographic evidence of a new infarct or stroke	Through hospital admission, average of 4 weeks
Secondary	Clinical outcome	Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)	2 years