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NCT Number: NCT07534722

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

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.

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Key information

Conditions

Type B Aortic Dissection

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 contact

Michelle Jenkerson

CONTACT

[email protected]

3143625626

Mohamed Zayed

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Prior Aortic Dissections
  • Genetic aortpathies
  • Iatrogenic aortic dissection related to prior procedure(s)

Treatment and study plan

Auricular Vagus Nerve Stimulator

Device

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.

3D Printed Earpiece

Device

The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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)

  2. Role of taVNS in surgical intervention rates

    Time frame: Up to 2 weeks

    Identify the role of taVNS in surgical intervention rates

  3. 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

  4. 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

  5. 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.

Study contacts

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

Kelly Koogler, RN, BSN

CONTACT

[email protected]

3142861506

Mohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC

CONTACT

[email protected]

(314) 362-5648

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: taVNS for TBAD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

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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