Coronavirus, Covid19
Conditions
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.
Interventions
DEVICESoterix 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.
DEVICESoterix 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.
Sponsors
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score of Patient Health Questionnaire-9 | 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. |
Countries
United States
Participant flow
Recruitment details
One participant was removed after consent for failure to satisfy all inclusion requirements.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 6 |
| 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.
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. | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Active-Active Stimulation Group | Total | Sham-Active Stimulation Group |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 10.2 | 48.3 years STANDARD_DEVIATION 10.8 | 46.2 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 12 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 12 Participants | 6 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 2 / 6 |
| other Total, other adverse events | 0 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
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.
Time frame: Baseline and week 4 (End of Treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active-Active Stimulation Group | Change in Score of Patient Health Questionnaire-9 | -8.7 score on a scale | Standard Deviation 6.3 |
| Sham-Active Stimulation Group | Change in Score of Patient Health Questionnaire-9 | -5.5 score on a scale | Standard Deviation 4.1 |