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NCT Number: NCT04557618

Auricular VNS Following Subarachnoid Hemorrhage

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

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Key information

Conditions

Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Anna Huguenard, MD

CONTACT

[email protected]

3144506698

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular vagus nerve stimulation

Device

Transcutaneous auricular vagal nerve stimulation

Sham Auricular vagus nerve stimulation

Device

Transcutaneous auricular vagal nerve ear clip applied without current

Primary outcomes

  1. Inflammatory markers in the serum on admission

    Time frame: On hospital day 1

    TNF alpha from blood draw

  2. Change in inflammatory markers in the serum

    Time frame: Through hospital admission, average of 4 weeks

    TNF alpha from blood draws

  3. Inflammatory markers in the CSF on admission

    Time frame: On hospital day 1

    TNF alpha from cerebrospinal fluid

  4. Change in inflammatory markers in the CSF

    Time frame: Through hospital admission, average of 4 weeks

    TNF alpha from cerebrospinal fluid

  5. Cerebral vasospasm

    Time frame: Through hospital admission, average of 4 weeks

    Presence of moderate/severe radiographic vasospasm

  6. Hydrocephalus

    Time frame: Through hospital admission, average of 4 weeks

    Need for permanent CSF diversion via a ventricular shunt

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Hydrocephalus

    Time frame: Through hospital admission, average of 4 weeks

    Duration of temporary CSF diversion via an external ventricular drain

  8. Clinical outcome

    Time frame: 2 years

    Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna L Huguenard, MD

CONTACT

[email protected]

3144506698

Sponsors and collaborators

Lead sponsor

Anna Huguenard

Other

Registry information

Official study title

Transcutaneous Auricular Vagus Nerve Stimulation Following Spontaneous Subarachnoid Hemorrhage

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Sep 21, 2020
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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