Transcutaneous Auricular Vagus Nerve Stimulation for Attenuation of Inflammatory Response and Blood Pressure in Type B Aortic Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular Vagus Nerve Stimulator, 3D Printed Earpiece.
- Who it may be relevant to
- Registry conditions: Type B Aortic Dissection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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 deli - Device 3D Printed Earpiece
The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group.
Primary outcome measures
- Role of taVNS on serum CRP [Time frame: 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]
Secondary outcome measures (5)
- Role of taVNS in mitigation of dissection propagation or evolution [Time frame: Day 3, Day 30]
- Role of taVNS in surgical intervention rates [Time frame: Up to 2 weeks]
- Role of taVNS in impulse control dosing [Time frame: 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]
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Publications
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07534722 · 202511116 · T32HL170959