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

NCT07534722 | Not Yet Recruiting FDA Device

• 2 other identifiers: 202511116T32HL170959
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type B Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• Role of taVNS on serum CRP

  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

  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 Outcomes (5)

• Role of taVNS in mitigation of dissection propagation or evolution

  Day 3, Day 30

• Role of taVNS in surgical intervention rates

  Up to 2 weeks

• Role of taVNS in impulse control dosing

  Up to 2 weeks

• 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

  Timeframe is defined formally as total hospital length of stay or 2 weeks, whichever is shorter

Study Arms (2)

Treatment Cohort

EXPERIMENTAL

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; Device: 3D Printed Earpiece

Nontreatment Cohort

PLACEBO COMPARATOR

The nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered.

Device: 3D Printed Earpiece

Interventions

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.

Treatment Cohort

3D Printed Earpiece DEVICE

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

Nontreatment Cohort; Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

• Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598.

  PMID: 38746275 BACKGROUND

• Liu FJ, Wu J, Gong LJ, Yang HS, Chen H. Non-invasive vagus nerve stimulation in anti-inflammatory therapy: mechanistic insights and future perspectives. Front Neurosci. 2024 Nov 13;18:1490300. doi: 10.3389/fnins.2024.1490300. eCollection 2024.

  PMID: 39605787 BACKGROUND

• Schillinger M, Domanovits H, Bayegan K, Holzenbein T, Grabenwoger M, Thoenissen J, Roggla M, Mullner M. C-reactive protein and mortality in patients with acute aortic disease. Intensive Care Med. 2002 Jun;28(6):740-5. doi: 10.1007/s00134-002-1299-1. Epub 2002 Apr 23.

  PMID: 12107680 BACKGROUND

• Vrsalovic M, Vrsalovic Presecki A. Admission C-reactive protein and outcomes in acute aortic dissection: a systematic review. Croat Med J. 2019 Aug 31;60(4):309-315. doi: 10.3325/cmj.2019.60.309.

  PMID: 31483116 BACKGROUND

• Patel AY, Eagle KA, Vaishnava P. Acute type B aortic dissection: insights from the International Registry of Acute Aortic Dissection. Ann Cardiothorac Surg. 2014 Jul;3(4):368-74. doi: 10.3978/j.issn.2225-319X.2014.07.06.

  PMID: 25133099 BACKGROUND

• Lombardi JV, Hughes GC, Appoo JJ, Bavaria JE, Beck AW, Cambria RP, Charlton-Ouw K, Eslami MH, Kim KM, Leshnower BG, Maldonado T, Reece TB, Wang GJ. Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) reporting standards for type B aortic dissections. J Vasc Surg. 2020 Mar;71(3):723-747. doi: 10.1016/j.jvs.2019.11.013. Epub 2020 Jan 27.

  PMID: 32001058 BACKGROUND

Central Study Contacts

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

CONTACT

(314) 362-5648; zayedm@wustl.edu

Kelly Koogler, RN, BSN

CONTACT

3142861506; kooglerk@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: April 16, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)