Recruiting

Transcutaneous Auricular Vagal Nerve Stimulation

Sponsor:

Washington University School of Medicine

Code:

NCT07404852

Conditions

Large Vessel Occlusion

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

transcutaneous auricular vagal nerve stimulation

Sham transcutaneous vagal nerve stimulation

Study Details

Brief summary:

This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory and brain injury laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagal nerve stimulation.

Conditions

Large Vessel Occlusion

Acute Ischemic Stroke

Study ID

NCT07404852

Start date

Feb 23, 2026

Status verified date

Feb, 2026

Completion date

Feb 29, 2028

Anticipated

Primary completion date

Nov 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients who present with acute ischemic strokes due to large vessel occlusions

Exclusion Criteria:

  • <18 years old
  • patients with presumed chronic large vessel occlusions
  • NIHSS<6
  • pre-morbid modified Rankin score (mRS) >2
  • unable to initiate treatment under 24 hours from symptom discovery
  • Chronic or acute infection, Recent surgery, active immune disease
  • life expectancy <3 months
  • patients' undergoing active cancer or immunosuppressive/modulating therapy
  • patients with sustained bradycardia on arrival with a heart rate <50 beats per minute.

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment - Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator

All patients will be fitted with the device, the investigator will attach an electrode to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period, the investigator will stimulate the auricular branch of the vagus nerve. Patients' will be treated with the following parameters: frequency 20 Hz, pulse width 250 μm, and and a fixed intensity of 0.5 milliampere.

sham comparator: Control - No Stimulation Transcutaneous Auricular Vagal Nerve Stimulator

All patients will be fitted with the device, the investigator will attach an electrode to the left ear. Sham stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients assigned to the controls arm will have no electricity applied to the auricular branch of the vagus nerve.

Interventions

transcutaneous auricular vagal nerve stimulation

Stimulus of the auricular branch of the vagal nerve with the transcutaneous auricular vagal nerve stimulation.

Sham transcutaneous vagal nerve stimulation

Patients assigned to the controls arm will have no electricity applied to the Auricular Branch of the Vagus Nerve.

Primary outcome measure

  • Brain Derived Tau [ Time Frame: 7 days ]
  • Neurofilament light chain [ Time Frame: 7 days ]
  • Interleukin - 1b - Changes and Differences in the Levels [ Time Frame: 7 days ]
  • Interleukin - 6 - Changes and Differences in the Levels [ Time Frame: 7 days ]
  • Tumor Necrosis Factor Alpha - Changes and Differences in the Levels [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Angela Birke, MS

(314) 362-5291birkea@wustl.edu

Osvaldo Laurido-Soto, MD

314-273-3294ojlaurido-soto@wustl.edu

Locations

Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Angela Birke, MS

(314) 362-5291birkea@wustl.edu

Osvaldo J Laurido-Soto, MD

ojlaurido-soto@wustl.edu

Principal Investigator:

Osvaldo J Laurido-Soto, MD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Apr 13, 2026

Last verified

Feb, 2026

Keywords

  • Acute ischemic stroke
  • large vessel occlusion
  • cytokines
  • vagus nerve stimulator
  • brain injury biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-04-13.