Auricular VNS Following Intracerebral Hemorrhage
Purpose
This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.
Condition
- Intracerebral Hemorrhage
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital
Exclusion Criteria
- Patients < 18 years old - Patients with a presumed traumatic etiology for their ICH, infratentorial location, ICH volume > 60 ml or < 10 ml, at risk of imminent death (e.g. Glasgow Coma Scale, GCS of 3 or one or more pupils unreactive), surgical intervention imminently planned (not including ventriculostomy) - Patients undergoing active cancer therapy - Patients with sustained bradycardia on arrival with a heart rate < 50 beats per minute. - Patients who cannot be enrolled within 48 hours of the initial bleed.
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 placed in their ear twice daily, without the stimulation applied |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06799390
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
Detailed Description
Vagal nerve stimulation (VNS) has been studied as a novel method of reducing inflammation, and it has been successfully used in animal models of inflammatory conditions. The purpose of the proposed study is to determine if transcutaneous auricular VNS will impact inflammatory markers in the blood and cerebrospinal fluid (CSF) in patients with intracerebral hemorrhage, 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 the development of peri-hematomal edema, interventions for edema (medical or surgical), and intensive care unit and hospital stay. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge. No additional appointments will be made specially for the research study.