Clinical trial NCT06799390: Auricular VNS Following Intracerebral Hemorrhage
Official title: Vagus Nerve Stimulation Following Intracerebral Hemorrhage (IHC) to Mitigate ICH-induced Inflammation and Cerebral Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracerebral Hemorrhage
Keywords: vagal nerve stimulation
pathologic processes
intracerebral hemmorrhage
cerebrovascular disorders
brain diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Hemorrhage
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 80
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 intracerebral hemorrhage.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the inflammatory marker IL-6 in plasma
timeFrame: 14 days
measure: Growth of perihematomal edema
timeFrame: 14 days
measure: Neurological worsening
timeFrame: Through hospital admission, average 14 days
Secondary outcomes:
measure: Change in additional inflammatory markers in plasma
timeFrame: 14 days
measure: Change in inflammatory markers in cerebrospinal fluid
timeFrame: 14 days
measure: Relative perihematomal edema
timeFrame: 14 days
measure: Neurological outcome
timeFrame: 2 years
measure: Hospital length of stay
timeFrame: Through hospital admission, average 14 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Eric Leuthardt, MD MBA
role: STUDY_CHAIR
References:
citation: Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598.
citation: Huguenard A, Tan G, Johnson G, Adamek M, Coxon A, Kummer T, Osbun J, Vellimana A, Limbrick D Jr, Zipfel G, Brunner P, Leuthardt E. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. PLoS One. 2024 Aug 23;19(8):e0301154. doi: 10.1371/journal.pone.0301154. eCollection 2024.
citation: Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial. Elife. 2025 Jan 9;13:RP100088. doi: 10.7554/eLife.100088.