Transcutaneous Auricular Vagus Nerve Stimulation for Attenuation of Inflammatory Response and Blood Pressure in Type B Aortic Dissection (taVNS for TBAD)

April 15, 2026 updated by: Washington University School of Medicine

Patients with uncomplicated Type B aortic dissections (TBAD) are traditionally treated in the ICU for impulse control, with BP and HR goals. Local and systemic inflammation often is a resulting consequence of acute aortic dissection. Vagus nerve stimulation can impact hemodynamics and inflammation. This study will utilize a novel transcutaneous auricular vagus nerve stimulator (taVNS) as part of the treatment for patients with TBAD. It's hypothesized that vagus nerve stimulation may provide benefit to the acute TBAD population admitted to ICU by two distinct mechanisms:

  1. Through upregulation of parasympathetic pathways which may augment chemical heart rate and blood pressure control through bioelectric stimulation, and
  2. downregulation of inflammatory pathways through a neuro-immunological axis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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

  • Name: Mohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC
  • Phone Number: (314) 362-5648
  • Email: zayedm@wustl.edu

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Mohamed Zayed

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adults age 18 years and older.
  2. Presenting with acute, uncomplicated TBAD
  3. Ability to enroll within 24 hours of presentation

Exclusion Criteria:

  1. Prior Aortic Dissections
  2. Genetic aortpathies
  3. Iatrogenic aortic dissection related to prior procedure(s)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Cohort
The treatment cohort will undergo transcutaneous auricular nerve stimulation using an in-house 3D printed earpiece fitted with an off-the-shelf stimulation device
Device: Auricular Vagus Nerve Stimulator
Patients will be randomized to treatment with taVNS or placebo. The treatment cohort will undergo transcutaneous auricular vagus nerve stimulation using an in-hose 3D printed earpiece fitted with an off-the-shelf stimulation device (Soterix Medical). Stimulation will occur for 20 minutes, twice daily for 14 days or until discharge, whichever occurs first. The nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered.
Device: 3D Printed Earpiece
The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group.
Placebo Comparator: Nontreatment Cohort
The nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered.
Device: 3D Printed Earpiece
The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of taVNS on serum CRP
Time Frame: Day 1, 3, 7, and 14 should the patient still be admitted.
Identify if taVNS can change serum CRP over 2 weeks in patients with acute type B aortic dissections.
Day 1, 3, 7, and 14 should the patient still be admitted.
Role of taVNS on dissection related end-organ deficits
Time Frame: through study completion, an average of 1 year
Identify if in the acute period (2 weeks) following type B aortic dissections, if taVNS can change the incidence of mesenteric, renal, and limb-related ischemic events
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of taVNS in mitigation of dissection propagation or evolution
Time Frame: Day 3, Day 30
Identify if taVNS utilization in the acute period (2 weeks) following type B aortic dissection can lead to a change in aortic dissection propagation based on interval CT imaging (3 days, 1 month)
Day 3, Day 30
Role of taVNS in surgical intervention rates
Time Frame: Up to 2 weeks
Identify the role of taVNS in surgical intervention rates
Up to 2 weeks
Role of taVNS in impulse control dosing
Time Frame: Up to 2 weeks
Volume and maximum doses of intravenous impulse control medications, including esmolol and nicardipine, across a period of up to 2 weeks
Up to 2 weeks
Role of taVNS in ICU and hospital length of stay
Time Frame: Treatment to hospital discharge, expected to occur, on average, between 1-2 weeks from admission/initial treatment
Identify the role of taVNS in ICU and hospital length of stay
Treatment to hospital discharge, expected to occur, on average, between 1-2 weeks from admission/initial treatment
Role of taVNS in the healthcare economics
Time Frame: Timeframe is defined formally as total hospital length of stay or 2 weeks, whichever is shorter
Correlation between taVNS for Type B aortic dissections and total cost of care in a given hospital admission. Outcome metric is total medical costs associated with the hospital admission (dollars), to be obtained from the hospital registrar and billing services.
Timeframe is defined formally as total hospital length of stay or 2 weeks, whichever is shorter

Collaborators and Investigators

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

Sponsor

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 (Estimated)

April 17, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 202511116
  • T32HL170959 (U.S. NIH Grant/Contract)

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

Yes

product manufactured in and exported from the U.S.

Yes

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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