Recruiting

Auricular VNS

Sponsor:

Anna Huguenard

Code:

NCT04557618

Conditions

Subarachnoid Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Auricular Vagus Nerve Stimulation

Sham Auricular Vagus nerve Stimulation

Study Details

Brief summary:

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

Conditions

Subarachnoid Hemorrhage

Study ID

NCT04557618

Start date

Jan 5, 2021

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Auricular VNS Stimulation

Participants receive twice daily 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

Interventions

Auricular Vagus Nerve Stimulation

Transcutaneous auricular vagal nerve stimulation

Sham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve ear clip applied without current

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Anna L Huguenard, MD

3144506698ahuguenard@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Anna Huguenard, MD

3144506698ahuguenard@wustl.edu

More Information

Sponsor

Anna Huguenard

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

  • Vagal nerve stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anna Huguenard on 2025-12-26.