Type B Aortic DissectiontaVNS for TBADNCT07534722
Transcutaneous Auricular Vagus Nerve Stimulation for Attenuation of Inflammatory Response and Blood Pressure in Type B Aortic Dissection
A study testing Auricular Vagus Nerve Stimulator and 3D Printed Earpiece in people with Type B Aortic Dissection, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type B Aortic Dissection
- What is being tested?
- Auricular Vagus Nerve Stimulator and 3D Printed Earpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 years and older.
- Presenting with acute, uncomplicated TBAD
- Ability to enroll within 24 hours of presentation
Who cannot join
- Prior Aortic Dissections
- Genetic aortpathies
- Iatrogenic aortic dissection related to prior procedure(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
Michelle Jenkerson, 3143625626, jenkerson_m@wustl.edu
Mohamed Zayed
About this study
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:
- Through upregulation of parasympathetic pathways which may augment chemical heart rate and blood pressure control through bioelectric stimulation, and
- downregulation of inflammatory pathways through a neuro-immunological axis.
- Conditions
- Type B Aortic Dissection
- Being tested
- Auricular Vagus Nerve Stimulator, 3D Printed Earpiece
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Vagus Nerve StimulatorDevice
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 EarpieceDevice
The earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: 3D Printed Earpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of taVNS on serum CRP
Identify if taVNS can change serum CRP over 2 weeks in patients with acute type B aortic dissections.
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
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)
Measured: Day 3, Day 30
Role of taVNS in surgical intervention rates
Identify the role of taVNS in surgical intervention rates
Measured: Up to 2 weeks
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
Measured: Up to 2 weeks
Role of taVNS in ICU and hospital length of stay
Identify the role of taVNS in ICU and hospital length of stay
Measured: Treatment to hospital discharge, expected to occur, on average, between 1-2 weeks from admission/initial treatment
Role of taVNS in the healthcare economics
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.
Measured: Timeframe is defined formally as total hospital length of stay or 2 weeks, whichever is shorter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start17 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type B Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534722
- Sponsor's protocol ID
- 202511116
- Other IDs
- T32HL170959
- Acronym
- taVNS for TBAD
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 38746275Liu 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.
PubMed 39605787Schillinger 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.
PubMed 12107680Vrsalovic 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.
PubMed 31483116Patel 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.
PubMed 25133099Lombardi 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.
PubMed 32001058
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation for Attenuation of Inflammatory Response and Blood Pressure in Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT07534722
- Acronym / sponsor ID
- taVNS for TBAD / 202511116
- Conditions
- Type B Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 17 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Through upregulation of parasympathetic pathways which may augment chemical heart rate and blood pressure control through bioelectric stimulation, and
- downregulation of inflammatory pathways through a neuro-immunological axis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort | Experimental | Device: Auricular Vagus Nerve Stimulator, Device: 3D Printed EarpieceThe treatment cohort will undergo transcutaneous auricular nerve stimulation using an in-house 3D printed earpiece fitted with an off-the-shelf stimulation device |
| Nontreatment Cohort | Placebo comparator | Device: 3D Printed EarpieceThe nontreatment cohort (placebo cohort) will have an identical device fitted with planned therapy sessions without any electrical pulses delivered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults age 18 years and older.
- Presenting with acute, uncomplicated TBAD
- Ability to enroll within 24 hours of presentation
Key exclusion criteria (3 listed)
- Prior Aortic Dissections
- Genetic aortpathies
- Iatrogenic aortic dissection related to prior procedure(s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Vagus Nerve StimulatorPatients 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. | Device | Treatment Cohort |
| 3D Printed EarpieceThe earpiece will be utilized for both cohorts and fitted with the stimulation device for the treatment group. | Device | Nontreatment Cohort, Treatment Cohort |
Primary outcome
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.
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 38746275Huguenard 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.
- Background: PubMed 39605787Liu 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.
- Background: PubMed 12107680Schillinger 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.
- Background: PubMed 31483116Vrsalovic 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.
- Background: PubMed 25133099Patel 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.
- Background: PubMed 32001058Lombardi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Vagus Nerve Stimulator and 3D Printed Earpiece in people with Type B Aortic Dissection, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Zayed, MD, PhD, MBA, DFSVS, FAHA, FAC ((314) 362-5648, zayedm@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of taVNS on serum CRP (time frame: Day 1, 3, 7, and 14 should the patient still be admitted.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07534722, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.