NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • COVID positive - At home - Afebrile - Anxiety - Depression - Vertigo - Anosmia - Headaches - Irritability - Cognitive Processing

Exclusion Criteria

  • Damage to left ear anatomy - Unstable hemodynamic effects - Ischemic or hemorrhagic stroke after developing COVID - Unable to give consent, follow instructions - Unable to read or write or speak English - No access to home WiFi

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active-Active Stimulation Group 		This group will be randomized into the active stimulation group for weeks 1&2 of stimulation and active stimulation during weeks 3&4 of stimulation of study participation.
  • 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.
Sham Comparator
Sham-Active Stimulation Group 		This group will be randomized into the sham stimulation group for weeks 1&2 of stimulation and active stimulation for weeks 3&4 of stimulation of study participation.
  • 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.

Recruiting Locations

More Details

NCT ID
NCT04638673
Status
Completed
Sponsor
Medical University of South Carolina