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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults age 18 years and older.

Presenting with acute, uncomplicated TBAD

Ability to enroll within 24 hours of presentation

Disqualifiers

Prior Aortic Dissections

Genetic aortpathies

Iatrogenic aortic dissection related to prior procedure(s)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Treatment CohortExperimental treatment 2 interventions
Group B: Nontreatment CohortPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Role of taVNS on serum CRP

Identify if taVNS can change serum CRP over 2 weeks in patients with acute type B aortic dissections.

Time frame
Day 1, 3, 7, and 14 should the patient still be admitted.
2

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

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Role of taVNS in mitigation of dissection propagation or evolution

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)

Time frame
Day 3, Day 30
2

Role of taVNS in surgical intervention rates

Identify the role of taVNS in surgical intervention rates

Time frame
Up to 2 weeks
3

Role of taVNS in impulse control dosing

Volume and maximum doses of intravenous impulse control medications, including esmolol and nicardipine, across a period of up to 2 weeks

Time frame
Up to 2 weeks
4

Role of taVNS in ICU and hospital length of stay

Identify the 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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: