Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronavirus
- Sponsor
- Medical University of South Carolina
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Change in Score of Patient Health Questionnaire-9
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Mark S. George , MD
Distinguished University Professor
Medical University of South Carolina
Eligibility Criteria
Inclusion Criteria
- •COVID positive
- •Depression
- •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
Outcomes
Primary Outcomes
Change in Score of Patient Health Questionnaire-9
Time Frame: Baseline and week 4 (End of Treatment)
The Patient Health Questionnaire-9 (PHQ-9) is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. Scores range from 0-27. Higher scores mean worse symptoms. Remission -minimal to absence of symptoms; PHQ-9 score \< 5. Response -50% or greater decrease in PHQ-9 baseline severity; residual symptoms remain. Partial Response -26% to 49% decrease in PHQ-9 baseline severity. Non-response -less than 25% decrease in PHQ-9 baseline severity.