Auricular VNS Following Subarachnoid Hemorrhage

December 18, 2025 updated by: Anna Huguenard

Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular VNS Stimulation
Participants receive twice daily auricular vagal nerve stimulation
Device: Auricular Vagus Nerve Stimulation
Transcutaneous 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
Device: Sham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve ear clip applied without current

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory markers in the serum on admission
Time Frame: On hospital day 1
TNF alpha from blood draw
On hospital day 1
Change in inflammatory markers in the serum
Time Frame: Through hospital admission, average of 4 weeks
TNF alpha from blood draws
Through hospital admission, average of 4 weeks
Inflammatory markers in the CSF on admission
Time Frame: On hospital day 1
TNF alpha from cerebrospinal fluid
On hospital day 1
Change in inflammatory markers in the CSF
Time Frame: Through hospital admission, average of 4 weeks
TNF alpha from cerebrospinal fluid
Through hospital admission, average of 4 weeks
Cerebral vasospasm
Time Frame: Through hospital admission, average of 4 weeks
Presence of moderate/severe radiographic vasospasm
Through hospital admission, average of 4 weeks
Hydrocephalus
Time Frame: Through hospital admission, average of 4 weeks
Need for permanent CSF diversion via a ventricular shunt
Through hospital admission, average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stressed-induced cardiomyopathy
Time Frame: Through hospital admission, average of 4 weeks
Presence of stressed-induced cardiomyopathy based on any of the following criteria: 1) New troponin elevation, 2) New EKG changes (specifically ST segment elevation, ST segment depression, left bundle branch block, prolonged QT interval), 3) New findings of cardiomyopathy on echocardiogram
Through hospital admission, average of 4 weeks
Cerebral ischemia
Time Frame: Through hospital admission, average of 4 weeks
Presence of cerebral ischemia based on the following criteria: Radiographic evidence of a new infarct or stroke
Through hospital admission, average of 4 weeks
Clinical outcome
Time Frame: 2 years
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
2 years
Inflammatory markers in the serum on admission
Time Frame: On hospital day 1
IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8from blood draws
On hospital day 1
Change in inflammatory markers in the serum
Time Frame: Through hospital admission, average of 4 weeks
IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8 from blood draws
Through hospital admission, average of 4 weeks
Inflammatory markers in the CSF on admission
Time Frame: On hospital day 1
IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, from cerebrospinal fluid
On hospital day 1
Change in inflammatory markers in the CSF
Time Frame: Through hospital admission, average of 4 weeks
IL-12, GM-CSF, IFN gamma, IL-1b, IL-10, IL-13, IL-17A, IL-2, IL-4, IL-5, IL-6, IL-8, from cerebrospinal fluid
Through hospital admission, average of 4 weeks
Cerebral vasospasm
Time Frame: Through hospital admission, average of 4 weeks
Additional features of vasospasm: 1) Number of vascular studies obtained, 2) Need for blood pressure augmentation or hypervolemia, 3) Need for intraarterial or intrathecal vasodilator, 4) Need for angioplasty
Through hospital admission, average of 4 weeks
Hydrocephalus
Time Frame: Through hospital admission, average of 4 weeks
Duration of temporary CSF diversion via an external ventricular drain
Through hospital admission, average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anna Huguenard

Investigators

  • Principal Investigator: Eric C Leuthardt, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

September 4, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202007034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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