Auricular VNS Following Subarachnoid Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular Vagus Nerve Stimulation, Sham Auricular Vagus nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Subarachnoid Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage
Overview
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.
Interventions
- Device Auricular Vagus Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation - Device Sham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve ear clip applied without current
Primary outcome measures
- Inflammatory markers in the serum on admission [Time frame: On hospital day 1]
- Change in inflammatory markers in the serum [Time frame: Through hospital admission, average of 4 weeks]
- Inflammatory markers in the CSF on admission [Time frame: On hospital day 1]
- Change in inflammatory markers in the CSF [Time frame: Through hospital admission, average of 4 weeks]
- Cerebral vasospasm [Time frame: Through hospital admission, average of 4 weeks]
- Hydrocephalus [Time frame: Through hospital admission, average of 4 weeks]
Secondary outcome measures (9)
- Inflammatory markers in the serum on admission [Time frame: On hospital day 1]
- Change in inflammatory markers in the serum [Time frame: Through hospital admission, average of 4 weeks]
- Inflammatory markers in the CSF on admission [Time frame: On hospital day 1]
- Change in inflammatory markers in the CSF [Time frame: Through hospital admission, average of 4 weeks]
- Cerebral vasospasm [Time frame: Through hospital admission, average of 4 weeks]
- Cerebral ischemia [Time frame: Through hospital admission, average of 4 weeks]
- Hydrocephalus [Time frame: Through hospital admission, average of 4 weeks]
- Clinical outcome [Time frame: 2 years]
- Stressed-induced cardiomyopathy [Time frame: Through hospital admission, average of 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Publications
- 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. PMID 39786346
- 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. PMID 39178291
- 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. PMID 38746275
- 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 safety study. medRxiv [Preprint]. 2024 Sep 8:2024.04.03.24304759. doi: 10.1101/2024.04.03.24304759. PMID 38633771
- Huguenard AL, Tan G, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD Jr, Zipfel GJ, Brunner P, Leuthardt EC. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. medRxiv [Preprint]. 2024 Mar 19:2024.03.18.24304239. doi: 10.1101/2024.03.18.24304239. PMID 38562875
Identifiers
NCT: NCT04557618 · 202007034