CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Soterix taVNS model 0125-LTE Stimulator - Active-Active Group +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04638673
NCT04638673Phase 2Completed
CompareCT.gov

Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab

Medical University of South Carolina·interventional·Posted Nov 20, 2020·Updated Jul 26, 2022

In Brief

A Phase 2 clinical trial evaluating Soterix taVNS model 0125-LTE Stimulator - Active-Active Group and Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group for Coronavirus and Covid19. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant's ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone or computer. The study team is investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronavirus, Covid19
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 20, 2020
Enrollment StartNov 19, 2020
Primary CompletionJun 30, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.6 years ago

Interventions

Soterix taVNS model 0125-LTE Stimulator - Active-Active Groupdevice

Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.

Soterix taVNS model 0125-LTE Stimulator - Sham-Active Groupdevice

Participants will receive sham taVNS stimulation for weeks 1\&2 and active stimulation for weeks 3\&4 of the stimulation portion of this study.