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NCT06767241

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

Completed NA Last updated 9 January 2025
What this trial tests

NA trial testing Non-invasive auricular vagus nerve stimulation in COVID-19 in 83 participants. Completed in 31 March 2022.

Timeline
1 January 2021
Primary endpoint
31 December 2021
31 March 2022

Quick facts

Lead sponsorUniversity of Medicine and Pharmacy "Victor Babes" Timisoara
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment83
Start date1 January 2021
Primary completion31 December 2021
Estimated completion31 March 2022
Sites1 location across Romania

Drugs / interventions tested

Conditions studied

Sponsor

University of Medicine and Pharmacy "Victor Babes" Timisoara

Who can join

Eligibility, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Non-invasive auricular vagus nerve stimulation

Trials testing the same drug.

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other University of Medicine and Pharmacy "Victor Babes" Timisoara trials

Trials by the same sponsor.

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Data sources for this page

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