Neuromodulation for Septic Shock

This study is looking at a new way to treat septic shock, a life-threatening condition where your body's response to infection causes organ damage. Researchers are testing a device called Parasym that delivers Low Level Transcutaneous Vagus Nerve Stimulation. This involves gently stimulating a nerve in your ear to help your body regulate inflammation and balance your nervous system. The study aims to see if this stimulation can reduce inflammation, specifically by measuring changes in a substance called Tumor Necrosis Factor Alpha (an inflammatory cytokine). You may be able to join if you are 18 or older and have septic shock. The study is currently unclear on its recruitment status and plans to enroll 34 participants.

Study design
This interventional study plans to enroll 34 participants with septic shock to test a device for vagus nerve stimulation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure changes in inflammation at 4 hours and 24 hours after stimulation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03992378

Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis

Recruiting
NAAges 18+InterventionalTreatment
University of Oklahoma
~34 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Low Level Transcutaneous Vagus Nerve Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Inflammatory Cytokine Tumor Necrosis Factor Alpha
Measured over Baseline to 4 hours and baseline to 24 hours post stimulation
Septic Shock
1 sites across 1 states
Oklahoma1
  • Houssein Youness, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma
  • Zain Ul Abideen Asad, MD · PRINCIPAL_INVESTIGATOR · University of Oklahoma

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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
  • Change in Inflammatory Cytokine Tumor Necrosis Factor AlphaBaseline to 4 hours and baseline to 24 hours post stimulation

    Serum inflammatory cytokine