NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronavirus, Covid19

Intervention / Treatment
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* Device: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group
* Device: Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active-Active Stimulation Group<br>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<br>* Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.<br>|
| Sham Comparator: Sham-Active Stimulation Group<br>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<br>* Participants will receive sham taVNS stimulation for weeks 1&2 and active stimulation for weeks 3&4 of the stimulation portion of this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score of Patient Health Questionnaire-9 | 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. | Baseline and week 4 (End of Treatment) |