Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT03992378
Status
Recruiting
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Conditions

  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low Level Transcutaneous Vagus Nerve Stimulation — DEVICE
    Stimulation of the auricular branch of the vagus nerve at tragus of the external ear delivered by Parasym device.
  • Low Level Transcutaneous Vagus Nerve Stimulation — DEVICE
    Stimulation of the ear lobe delivered by Parasym device.

Study Details

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. It is the most expensive healthcare condition to treat in United States and has a mortality rate of nearly 30%. It is widely known that exaggerated inflammation and imbalance between sympathetic and parasympathetic arms of the autonomic nervous system (ANS) contribute to progression and adverse outcomes in sepsis. The role of unchecked inflammation and unregulated ANS as a potential treatment target is an important gap in our knowledge that should be explored. Cholinergic anti-inflammatory pathway (CAP) is an intricate network where the ANS senses inflammation by vagus nerve afferents and tries to regulate it by vagus nerve efferents to the reticuloendothelial system. The central hypothesis of this pilot clinical trial is that transcutaneous vagus nerve stimulation (TVNS) at tragus of the external ear can activate the CAP to suppress inflammation and improve autonomic imbalance as measured by inflammatory cytokine levels and heart rate variability (HRV) analysis. The investigators plan to randomize patients with septic shock into active and sham stimulation groups and study the effects of vagal stimulation on inflammatory cytokines, HRV and a clinical severity score of sepsis. Both groups will continue to receive the standard of care treatment for sepsis irrespective of group assignments. The investigators hypothesize that 4 hours of TVNS will suppress inflammatory markers and improve the balance between sympathetic and parasympathetic arms of ANS as measured by HRV, resulting in improved Sequential Organ Failure Assessment Score (SOFA). The preliminary data generated from this pilot study will lay the foundation for a larger clinical trial.

Key Dates

Start date
Oct 10, 2019
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Treatment
    Patients will receive a single 4-hour session of active transcutaneous vagus nerve stimulation.
  • Sham Comparator: Sham Control
    Patients will receive a single 4-hour session of sham transcutaneous vagus nerve stimulation.

Primary Outcome Measure

Change in Inflammatory Cytokine Tumor Necrosis Factor Alpha [ Time Frame: Baseline to 4 hours and baseline to 24 hours post stimulation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Houssein Youness, MD
[email protected]
405-271-6173

Find similar trials in Oklahoma City, OK

By research site
University of Oklahoma Health Sciences Center· Oklahoma City, OK

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