MedTrace Logo

Transcranial Non-invasive Electrical Stimulation of the Vagus Nerve in Hospitalized Moderate-to-severe COVID-19 Patients

NCT06767241 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-01-09

No results posted yet for this study

Summary

Subtle Pulse Electro-biological Recovery Apparatus (SPERA) is an innovative device which delivers digital subliminal pulse stimulation trans cranially to auricular branches of the central nervous system and modulates the anti-inflammatory reflexes mediated by afferent and efferent fibers of the Vagus Nerve. The aim of this single center, interventional study was to assess the efficacy and safety of non-invasive trans-cranial Direct Current auricular Vagus Nerve Stimulation (aVNS) delivered by SPERA in the resolution of inflammatory insults in patients with SARS-CoV-2 infection. Patients hospitalized with moderate-to-severe COVID-19 will be enrolled in the study. Inclusion criteria: RT-PCR confirmed SARS-CoV-2 infection, lung involvement as demonstrated by chest CT scan, increased risk for cytokine storm (CRP\>46mg/L, ferritin\>250ng/mL). Key exclusion criteria: critical patients upon admission, requiring ICU care. SPERA therapy will be administered on top of the standard of care treatment for consecutive patients satisfying the above mentioned criteria.

Conditions

Interventions

DEVICE

Non-invasive auricular vagus nerve stimulation

Non-invasive transcranial direct current auricular vagus nerve stimulation (tDC-aVNS)

OTHER

Standard Medical Therapy

Standard of care treatment for moderate to severe COVID-19

Sponsors & Collaborators

  • University of Medicine and Pharmacy "Victor Babes" Timisoara

    lead OTHER

Principal Investigators

  • Cristian Oancea, University Professor, MD, PhD · University of Medicine and Pharmacy "Victor Babes" Timisoara

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-31
Completion
2022-03-31

Countries

  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06767241 on ClinicalTrials.gov