Auricular VNS Following Subarachnoid Hemorrhage
Purpose
This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.
Condition
- Subarachnoid Hemorrhage
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants are assigned to either stimulation or sham stimulation arms
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
- Masking Description
- All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores will be assessed and recorded by clinicians blinded to treatment arm.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Auricular VNS Stimulation |
Participants receive twice daily auricular vagal nerve stimulation |
|
|
Sham Comparator Sham Auricular VNS Stimulation |
Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis, Missouri 63110
More Details
- NCT ID
- NCT04557618
- Status
- Recruiting
- Sponsor
- Anna Huguenard
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.