NCT04638673

NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus
• Covid19

Interventions

Type	Name	Description
DEVICE	Soterix taVNS model 0125-LTE Stimulator - Active-Active Group	Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
DEVICE	Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group	Participants will receive sham taVNS stimulation for weeks 1\&2 and active stimulation for weeks 3\&4 of the stimulation portion of this study.

Timeline

• Start date: 2020-11-19
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-11-20
• Last updated: 2022-07-26
• Results posted: 2022-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study