Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using nerve stimulation to manage inflammation in septic shock

Official title: Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis

Run by University of Oklahoma · NCT03992378 · Data updated 2026-11-12

This study is testing if a new ear stimulation technique can help reduce inflammation and improve recovery in patients with septic shock.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment34 (estimated)
SponsorUniversity of Oklahoma
Academic / other
Locations1 site (Oklahoma City, Oklahoma)
StatusRecruiting
StartedOctober 10, 2019
Main results expectedJune 2027
Study endsDecember 2027
Registry record updatedApril 1, 2026
Trial IDNCT03992378 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals diagnosed with septic shock who have persistent low blood pressure despite receiving adequate fluid resuscitation.

Probably not a fit

Patients with a history of certain heart conditions, autonomic dysfunction, or those who are pregnant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of transcutaneous vagus nerve stimulation (TVNS) to regulate inflammation and autonomic imbalance in patients suffering from septic shock. The study aims to activate the cholinergic anti-inflammatory pathway through non-invasive stimulation at the tragus of the ear, potentially leading to improved outcomes in sepsis management. By targeting the autonomic nervous system, the trial seeks to address a critical gap in current treatment approaches for this life-threatening condition.

Why it matters

Potential benefit: If successful, this approach could significantly reduce inflammation and improve survival rates in patients with septic shock.

How similar studies have gone: While the use of vagus nerve stimulation is a novel approach in the context of sepsis, similar studies in other inflammatory conditions have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Septic shock (meeting severe sepsis and having persistent systolic blood pressure \<90mmHg despite adequate fluid resuscitation).

Exclusion Criteria:

* Unilateral or bilateral vagotomy
* History of myocardial infarction or stroke in the last 1 year
* Recurrent vasovagal syncope
* Sick sinus syndrome without pacemaker
* Bifascicular heart block
* 2nd or 3rd-degree heart block
* Hypotension due to autonomic dysfunction
* Pregnant women
* Prisoners and patients with suicidal ideation

Where it's running

  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.