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

Conditions

• Type B Aortic Dissection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 3D Printed Earpiece — DEVICE
  The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group.

Study Details

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.

Key Dates

Start date

Apr 17, 2026

Status verified

Apr 2026

Primary completion

Apr 1, 2027

Completion

Apr 1, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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
• Placebo Comparator: Nontreatment Cohort
  The nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered.

Primary Outcome Measure

Role of taVNS on serum CRP [ Time Frame: Day 1, 3, 7, and 14 should the patient still be admitted. ]

Central Contacts

• Mohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC
  (314) 362-5648
  [email protected]
• Kelly Koogler, RN, BSN
  3142861506
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

Related Studies

• IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
  Recruiting · Duke University · Birmingham, Alabama