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Auricular VNS Following Subarachnoid Hemorrhage

NCT ID: NCT04557618

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2028-12-31

Brief Summary

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This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.

Detailed Description

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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.

Conditions

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Subarachnoid Hemorrhage

Keywords

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Vagal nerve stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to either stimulation or sham stimulation arms
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Auricular VNS Stimulation

Participants receive twice daily auricular vagal nerve stimulation

Group Type EXPERIMENTAL

Auricular Vagus Nerve Stimulation

Intervention Type DEVICE

Transcutaneous auricular vagal nerve stimulation

Sham Auricular VNS Stimulation

Participants will have an auricular vagal nerve stimulator applied twice daily, without the stimulation applied

Group Type SHAM_COMPARATOR

Sham Auricular Vagus nerve Stimulation

Intervention Type DEVICE

Transcutaneous auricular vagal nerve ear clip applied without current

Interventions

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Auricular Vagus Nerve Stimulation

Transcutaneous auricular vagal nerve stimulation

Intervention Type DEVICE

Sham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve ear clip applied without current

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anna Huguenard

OTHER

Sponsor Role lead

Responsible Party

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Anna Huguenard

Assistant Professor of Neurosurgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eric C Leuthardt, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anna L Huguenard, MD

Role: CONTACT

Phone: 3144506698

Email: [email protected]

Facility Contacts

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Anna Huguenard, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 39786346 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39178291 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38746275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38633771 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38562875 (View on PubMed)

Other Identifiers

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202007034

Identifier Type: -

Identifier Source: org_study_id