Clinical trial NCT04557618: Auricular VNS Following Subarachnoid Hemorrhage
Official title: Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subarachnoid Hemorrhage
Keywords: Vagal nerve stimulation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either stimulation or sham stimulation arms
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory markers in the serum on admission
timeFrame: On hospital day 1
measure: Change in inflammatory markers in the serum
timeFrame: Through hospital admission, average of 4 weeks
measure: Inflammatory markers in the CSF on admission
timeFrame: On hospital day 1
measure: Change in inflammatory markers in the CSF
timeFrame: Through hospital admission, average of 4 weeks
measure: Cerebral vasospasm
timeFrame: Through hospital admission, average of 4 weeks
measure: Hydrocephalus
timeFrame: Through hospital admission, average of 4 weeks
Secondary outcomes:
measure: Inflammatory markers in the serum on admission
timeFrame: On hospital day 1
measure: Change in inflammatory markers in the serum
timeFrame: Through hospital admission, average of 4 weeks
measure: Inflammatory markers in the CSF on admission
timeFrame: On hospital day 1
measure: Change in inflammatory markers in the CSF
timeFrame: Through hospital admission, average of 4 weeks
measure: Cerebral vasospasm
timeFrame: Through hospital admission, average of 4 weeks
measure: Cerebral ischemia
timeFrame: Through hospital admission, average of 4 weeks
measure: Hydrocephalus
timeFrame: Through hospital admission, average of 4 weeks
measure: Clinical outcome
timeFrame: 2 years
measure: Stressed-induced cardiomyopathy
timeFrame: Through hospital admission, average of 4 weeks
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Eric C Leuthardt, MD
role: PRINCIPAL_INVESTIGATOR
References: