Testing a Wearable Telemedicine-controllable taVNS Device for NeuroCovid Recovery and Rehab
Phase: PHASE2
Conditions: Coronavirus, Covid19
Sponsor: Medical University of South Carolina

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Protocol Title: Testing a wearable telemedicine-controllable taVNS device for NeuroCovid 
Recovery and Rehab
NCT04638673
Protocol Version 4 IRB Approval: 01/22/2021

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PROTOCOL TITLE:
Testing a wearable telemedicine-controllable taVNS device for NeuroCovid Recovery and
Rehab
PRINCIPAL INVESTIGATOR:

Mark S. George, MD

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1.0
Objectives / Specific Aims
Aim 1: Test a home based taVNS protocol for feasibility and efficacy in NeuroCovid 
patients. 
We will recruit 30 formerly COVID positive adults (ages 18-70) in order to have 24 
completers. We will enroll subjects who had a definite case of COVID (were antigen positive)
and are at home and are no longer in the hospital. They must also have a residual 
neuropsychiatric symptom(s) that started anew after COVID developed (NeuroCovid). We 
will refer to these subjects as ‘initially neurocovid and persisting’. We will also enroll those 
who were asymptomatic, were tested as COVID positive, and then developed NeuroCovid 
symptoms shortly after their testing. We call these subjects ‘initially asymptomatic with later 
Neurocovid’. (There are several Covid diseases which occur after the acute illness has 
passed, particular hypercoagulable states and thrombotic strokes and heart attacks.) 
Symptoms we will target include anxiety, depression, and other CNS symptoms (e.g., 
vertigo, anosmia, headaches, fatigue, irritability, cognitive processing, etc.). Subjects will be 
recruited from MUSC electronic records and local testing centers, with online phone screens,
consents and ratings. This study is pioneering in being entirely online and home-based. We 
will provide telemedicine-based device-use support on demand. There will be two 
experimental groups – initial active taVNS and initial sham stimulation. Subjects will be 
randomly assigned to each group for a two-week in-home intervention of two hours per day 
for six days per week of stimulation (active or sham). After the controlled 2-week period, all 
participants will continue in a 2-week open label arm. Outcomes will include vital signs 
recorded through the device, mood ratings and a cognitive battery assessing 
neuropsychiatric functioning and symptoms. These online ratings will be obtained at 
baseline, taVNS treatment weeks 1-4, and 2-, 4-, 6-, and 8- weeks after treatment. We will 
also assess feasibility and tolerability. The device will collect daily subjective patient data as 
well as heart rate, blood pressure and respiration during the treatments.
Aim 2: Test whether 2 or 4 weeks of stimulation differ. 
At the end of two weeks, all subjects will receive two more weeks of intervention, with all 
receiving active stimulation without breaking the blind. This has two purposes. First, all 
subjects will eventually receive active treatment, aiding IRB approval and recruitment. 
Second, it will examine two versus four weeks of stimulation. 
This work will provide pilot data for a subsequent clinical trial application to test at home 
taVNS technology for specific NeuroCovid symptoms. Importantly, the data gained on device
efficacy and in-home feasibility for NeuroCovid applications can be readily applied to a 
number of post-COVID disabilities and rehabilitation needs (e.g., COPD and other 
complications treated through immunomodulatory and respiratory therapy amenable to vagal
nerve action). We strongly believe this technology has great potential for treating those 
currently sick with or disabled by COVID. We simply don’t know what is in store one year 
from now, but it is likely that the aftershocks of this pandemic will be the defining backdrop of
the next decade. A strength of this proposal is that it will allow us to pivot in the directions of 
greatest need in one year with a multitude of potential therapeutic targets and benefits, once 
initial feasibility and efficacy of the taVNS home therapy protocol has been established. The 
research team is experienced and are leaders in neuromodulation research and are thus 
uniquely capable of successfully shepherding this pilot work into a funded clinical trial.

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2.0
Background
Unfortunately, Coronavirus disease of 2019 (COVID-19) can enter and directly infect 
the brain, creating direct neurologic and psychiatric problems. Some have coined the 
term ‘NeuroCovid’ to describe this direct CNS infection and damage and differentiate this 
aspect of the disease from the more widely discussed systemic pulmonary and 
cardiovascular effects. However, the direct effects of the virus and the subsequent 
individual immunologic response on the brain and related outcomes are unknown. Thus, 
we are also just now beginning to understand that after recovery from the acute and 
immediate infection, many patients are struggling with longer term CNS issues, like 
fatigue, anosmia, anxiety and depression. Researchers are asking “Are we facing a 
crashing wave of neuropsychiatric sequelae of COVID-19?1 Innovative therapeutic 
approaches, particularly home-based,2 are desperately needed. 
  Luckily, a new neuromodulation technique (Transcutaneous Auricular Vagus Nerve 
Stimulation – taVNS) can directly stimulate the brain and has important anti-inflammatory 
and other neuromodulatory functions that likely can aid with NeuroCovid recovery. taVNS
may help with the acute illness, and more importantly for the proposed work, with the 
long-term recovery from NeuroCovid. taVNS is a new, non-invasive neuromodulation 
approach combining: 1) convenience (e.g. ear clip) and potential for at home delivery; 2) 
tolerability, even extending to testing in neonates; and 3) direct mono-synaptic 
modulation of deep brain nuclei that regulate parasympathetic function. taVNS offers the 
ability to directly treat the brain, reducing neuroinflammation and potentially improving 
and facilitating recovery from a variety of COVID disorders. With the rapid clinical testing 
supported through this proposal, taVNS may help with the long-term recovery from 
COVID or NeuroCovid.  
   Preclinical and clinical trials show that implanted vagus nerve stimulation (VNS) may 
be an effective anti-inflammatory treatment and may improve outcomes in disorders with 
inflammation. VNS prevents septic shock and can stop anaphylactic shock. VNS 
activates the cholinergic anti-inflammatory pathway and targets different immune, 
proinflammatory, and other signaling pathways, as well as modulating heart rate and 
blood pressure. Cervical VNS is FDA approved to treat chronic depression and also 
helps with anxiety but is invasive and expensive ($30k per device). taVNS is a home-
based, less expensive, non-invasive alternative.
3.0
Intervention to be studied 
We will be using the Soterix Medical Handheld home based taVNS device. Our 
group has been using taVNS in a variety of clinical laboratory, office or ICU based 
studies, most of them monitored through this IRB. 3-10 This is the first MUSC 
protocol using home based taVNS. 
The Soterix device is a research device that is FDA cleared in terms of safety but 
is not FDA approved for any indication. More information can be found here. 
https://soterixmedical.com/research/tavns
This IRB and most others have found that taVNS is a minimal risk device and does
not require an FDA IDE. 
We have attached the device specifications from the manufacturer. 

Cervical VNS is FDA approved for medication resistant epilepsy as well as 
medication resistant depression (Livanova). FDA pivotal trials are underway 
for paired cervical VNS with rehab for stroke (microtransponder). Noninvasive

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cervical VNS is FDA approved for treating cluster headache (electrocore). To 
date there are no FDA approved indications for taVNS. 

We will use the device twice daily, six days/week for an initial 2-week double 
blind phase followed by an additional two weeks active open phase. Thus, 
subjects will get 24 or 48 actual sessions over 4 weeks. Those randomized to
active during the first two weeks will get twice as much overall taVNS as 
those who get sham during the first two weeks (25Hz, 500us pulse width, 60s
ON, 30s OFF, 1 hr. duration per session).Subjects will be given a training 
video to watch and will then have an online training session with the MUSC 
RA. They will be instructed how to administer the device. For the first 3 
sessions at least, the RA will be online watching them do this. They will 
prepare a checklist of how well the subject is doing the treatment. The patient
can then only administer the treatment alone if they are checked off. 
Treatments will be monitored online for as long as it takes for the participant 
to be checked off. 

Active stimulation will be in the proper location in the ear. Sham stimulation 
will be in the same location but there will be a small ramp up of the device, 
delivering stimulation for 20 seconds, and then it will be programmed to turn 
off, until the end of the session when it will turn on again for 20 secs. 
4.0
Study Endpoints 
Outcomes will include vital signs, mood ratings and a cognitive battery assessing 
neuropsychiatric functioning and symptoms, and will be obtained at baseline, 2, 3, 4, 5, 6,
8  and 12 weeks after treatment. We will also assess feasibility and tolerability. 
Primary Outcome:
As this is a pilot and exploratory study, the outcomes are largely descriptive. In terms of 
feasibility we will assess dropout rates and compliance and subjective ratings of the 
device and the online only study. In terms of safety we will assess changes in blood 
pressure and any syncope or other adverse events.  We will also examine changes in 
neuropsychiatric symptoms for patients presenting with different NeuroCovid symptoms. 
Secondary Outcome:
See above.
5.0
Inclusion and Exclusion Criteria/ Study Population
Study Population:
Our study population will include adult NeuroCovid patients, who qualify for the study 
regardless of race or sex. COVID patients will be outpatients. We have the following 
racial distribution of patients: 66% Black or African American, 30% Caucasian and 2% 
other; Ethnicity: 2% Hispanic, 98% non-Hispanic. For sex we expect the following: 60% 
males and 40% females as early data suggest that for some reason males do worse with 
COVID. We will enroll all patients who qualify regardless of sex, if they or their caregivers
consent to the study.  We will not include children in this study
Inclusion Criteria:
We will enroll subjects who were COVID positive, had some identifiable time of 
illness, and are home and afebrile. They then must also have some residual new 

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neuropsychiatric symptom that started after COVID developed. We will also enroll 
those who were asymptomatic, were tested as COVID positive, and then 
developed NeuroCovid symptoms. Inclusion symptoms include new onset anxiety,
depression, and other CNS symptoms (e.g., vertigo, anosmia, headaches, fatigue,
irritability, cognitive processing).
Exclusion Criteria:
Damage to left or right ear or anatomy that does not allow taVNS; unstable 
hemodynamic effects that make a novel clinical intervention unsafe; ischemic or 
hemorrhagic stroke after developing COVID, patient unable to give consent, or 
follow instructions, not able to read or write or speak English; no home WiFi.
6.0
Number of Subjects
We will recruit 30 COVID positive adults in order to have 24 completers. 
7.0
Setting
Subjects will be in their home for this trial. MUSC study staff will use an electronic tele-
consenting (Doxy.me) and rating platform to communicate with the subjects. 
8.0
Recruitment Methods
We will screen for formerly COVID positive people in our electronic medical record (Epic) 
who have given permission to be contacted for research. Through our electronic medical 
record, we will contact MUSC COVID positive patients at least 14 days after their last 
test, and ask if they have residual symptoms. Subjects will sign consents and complete 
assessments online. We will then serially administer a broad ranging and comprehensive 
online battery assessing neuropsychiatric functioning and symptoms. MUSC will ship the 
device to subjects and they will be educated on the device use. We will provide 
telemedicine-based device-use support on demand if they have questions. 
Please see the attached flyer. 
9.0
Consent Process
Subjects will sign consents and complete assessments online. Subjects will be consented
by Drs. George or Badran via a tele-consenting platform.
10.0
Study Design / Methods

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
Please see the study timeline above. Potential subjects will be phone 
screened and if appropriate scheduled for a consent meeting and then 
baseline assessments. They will then be given the video showing how to use 
the device. MUSC research assistants will then ship a device (and urine 
pregnancy test) to subjects. They will then have a training session online with
MUSC RA’s. Then, for each session initially they will do this online with 
MUSC RA’s watching and rating and assisting if needed. They will complete 
a checklist of how well the subject administers the device. After three 
sessions if the subject is competent, they will self administer the device after 
that if they wish. All subjects can ask to have the RA online during any and all
treatments if they wish. All sessions are immediately put into the database 
and the MUSC RA will daily monitor this and make sure the subject has 
correctly performed the session with no adverse events. If a subject misses a 
session the RA will call and talk about this. There will be immediate questions
before and after each session, as well as the weekly online battery. There are
also weekly online assessments and at 4,6,8 and 12 weeks after study start. 
Procedures performed to lessen the probability or magnitude of risks.
We are excluding subjects with strokes or who are hemodynamically 
unstable. All sessions will be seated or even reclined if there are 
problems. Initial sessions are done with the MUSC RA and Soterix staff 
online. All session data and heart rate are sent immediately to the 
database and will be checked daily by research staff. 
How all drugs and devices will be used in the research (e.g. dose, dosage 
form, etc.)
The device is taVNS applied to the left or right ear at two times the 
amplitude for perceptual threshold. This intensity of taVNS has been 

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used in MUSC IRB 1 monitored studies in Parkinson’s Disease, Stroke 
Patients, Newborns and healthy volunteers. The dose for each session 
is 25Hz, 500us pulse width, 60s ON, 30s OFF, 1 hr. duration.
Subjects will receive two treatment sessions/day, 6 days per week, for 
two weeks (randomized), for 24 treatments in the double-blind phase. All
subjects will then receive an additional two weeks – 24 more treatments.
For those initially randomized to active VNS, they will thus receive up to 
48 hours of VNS therapy. For those initially randomized to sham, they 
will still receive 24 sessions, or 24 hours of treatment. While this may 
seem like a lot, remember that cervical VNS is implanted and then 
stimulates on and off for many years. Thus, this dose is minimal 
compared to the large and safe database of VNS for epilepsy or 
depression. 
The source records, including medical or educational records that will be used 
to collect data about subjects. 
We will collect demographic and clinical data from the Epic Database. 
We will perform phone screens and then online consent and ratings. All 
ratings will be done online with data going into Redcap with secure 
access. All data collected from the device will also go to the secure 
online MUSC Redcap database. 
Describe data collection procedures (e.g. chart review, subject interview, etc.). 
Provide a description of all assessment instruments to be used. (Upload in 
eIRB all surveys, scripts, etc.) Include what data will be collected.
See above. We have uploaded all database questionnaires. 
12.0
Data Management 
All data will be stored in the Redcap database. The blind will be kept by the MUSC RA, 
but they will be blinded as well. Soterix will set the active or sham control from the 
company after being instructed by the MUSC RA about the randomization code number 
for that patient, but MUSC will have the unblind in terms of emergency. 
Information about the participant (including their identifiable private information and/or any
identifiable biospecimens) may have all of their identifiers removed and used for future
research studies or distributed to other researchers for future research without additional
informed consent from them or their legally authorized representative.
In rare cases, the device manufacturer, Soterix, may need access to minimal PHI (such 
as name, phone number and address) in the event there is a device malfunction. Well-
trained MUSC staff will make every attempt to resolve any issues before putting Soterix 
in direct contact with the participant.
At a high-level analysis, we will compare the group changes in neuropsychiatric 
questionnaires in active versus sham taVNS using repeated measures ANOVA from 
baseline to immediately after last treatment and then as well over the 3-month follow-up. 
Power analysis on primary outcome: As there is no real data yet on taVNS effects on 
NeuroCOVID patients, it is difficult to perform a formal power analysis. The repeated 
measures design in 15 active and 15 sham patients will allow us to detect differences 
with a large or moderate effect size to be used for calculating power and sample size for 
subsequent trials.

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13.0
Provisions to Monitor the Data to Ensure the Safety of Subjects 
Dr. George or his designee,  should  he  be  unavailable,  will  be  responsible  for
reporting all unanticipated problems or AEs to the IRB. The PI or some study team
member will be present for each patient and record AE's real time. Soterix will be
responsible for reporting any unanticipated device-related  AE's to FDA. All screening
data will be kept in a file on Redcap. Screening data collected from participants  who  do
not  qualify  for  the  study  will  be  securely destroyed.
Dr. Mark George, who is a board certified neurologist and psychiatrist, and Dr. 
Badran will oversee the device testing and technical use of the Soterix system. 
An independent Safety Monitoring Committee (SMC) will be formed to advise the study 
investigators. The SMC will review and evaluate accumulated study data to ensure 
safety. They also will make recommendations concerning continuation, modification, or 
termination of any of the taVNS studies. It will be composed of several prominent 
COVID experts and Dr. Jeff Borckardt, MUSC associate professor and assistant provost
who has extensive VNS, TMS, and tDCS experience.
The SMC will be notified immediately of any and all SAE's. We will report to the IRB the 
number of treatments held for HR or redness, discomfort.
Drs. George or Badran will obtain informed consent, during which participants or their 
guardians are fully advised on the research procedures to be used, the amount of time 
required of them, the possible risks and benefits of the procedures, their right to refuse 
their infant’s participation in the study without prejudice, their right to terminate 
participation at any moment without prejudice, and the name and telephone number of 
the principal investigator. The legal guardians of all subjects will be required to have 
legal ability to consent.
Regarding confidentiality, subjects are informed that the information they provide, as 
well as participation in the study, will be kept strictly confidential, with access limited to 
the research staff. The identity of subjects in databases will be protected with 
alphanumeric codes. All data will be kept in locked file cabinets or on secure servers 
designed for use and access by Brain Stimulation Lab members only.
14.0
Withdrawal of Subjects 

Describe anticipated circumstances under which subjects will be withdrawn 
from the research without their consent, including stopping participation for 
safety reasons.
taVNS has been a very safe procedure and we do not anticipate subject 
withdrawal due to taVNS side effects. We will be monitoring each session 
and if a patient is extremely hemodynamically sensitive to the device we 
might consider terminating. Severely worsening of symptoms would be 
another reason (for example, worsening of headaches). VNS is 
antidepressant, antinociceptive, anti-inflammatory and anxiolytic so we do 
not anticipate worsening in these areas. 

Describe any procedures for orderly termination of subjects by investigator.

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Any termination would involve online video conversations with subjects and 
follow the patterns used for in person documentation of the reasons and 
ensuring that patients have understanding and medical follow-up. 

Describe procedures that will be followed when subjects voluntarily withdraw
from the research, including partial withdrawal from procedures with 
continued data collection.
As with all research, a subject can withdraw from research at any time. We 
will honor this and make sure the patient is safe and has good options and 
care and will ship the device back to MUSC. 
15.0
Risks to Subjects
Ear Stimulation:
Ear stimulation is safe, however there are some risks associated with stimulating 
the ear: There may be local discomfort. This will likely be temporary. In extreme 
cases burns might occur. We will video monitor any potential burns and will stop 
stimulation and advise subjects to apply vitamin E cream. Tissue surrounding the 
ear may be sensitive, sore or feel slight numbness. Hopefully this will be temporary 
and will go away after stimulation is turned off. 
Potential Headache, Dizziness, and Facial Pain:
Ear stimulation might cause headaches or face pain, which should resolve shortly 
after treatment.
Safety in case of pregnancy
This protocol will exclude pregnant women. The risks of using taVNS with pregnant 
women are currently unknown. If in the screening and consent a patient is a woman
of childbearing age, we will send them by mail a urine pregnancy test. They will 
need to complete this and show the negative result to the RA on doxy.me. 
Potential decrease in heart rate:
Ear stimulation may slow heart rate. In rare cases (less than 1%) decreased blood 
pressure or fainting may occur. We expect no significant changes in heart rate or 
blood pressure, or fainting may occur. For the initial sessions all subjects will be 
stimulating while they are seated, never standing. We expect no significant 
changes in heart rate or blood pressure, but if this occurs, the study team will 
evaluate the situation and either decide that the patient should be dropped from the
study, or do all sessions laying on a couch, or with lower doses. 
Unknown Risks:
There is always the possibility of other risks for a relatively new technology. The 
Study team will let the participant know if they learn anything that might make the 
participant change their mind about participating in the study. 
Loss of Confidentiality:
There is a risk of a loss of confidentiality of personal information. Subjects are 
informed that the information they provide, as well as participation in the study, will 
be kept strictly confidential, with access limited to the research staff. The identity of 
subjects in databases will be protected with alphanumeric codes. All data will be 
kept in locked file cabinets or on secure servers designed for use and access by 
Brain Stimulation Lab members only.
Potential Randomization Risk: 
The treatment a subject receives may prove to be less effective or to have more 
side effects than the other study treatment(s) or other available treatments.
Questionnaire Risk: 

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There are no anticipated risks to the participant. However, the participant may feel 
that some of the questions we ask are stressful or upsetting. If they do not wish to 
answer a question, they may skip it and go to the next question, or they may stop 
immediately. Also, being assessed for study entry, including the possibility that they
may not meet criteria for entering the study may be distressing. If they become 
upset or distressed as a result of their participation in the research project, the 
research team will be able to arrange for a one on one meeting with our team 
psychiatrist. 
Our commitment to patients is to take all reasonable steps to help them find 
treatments for worsening psychiatric symptoms. If the subject’s psychiatric 
conditions worsen (specifically suicidality or suicide ideation), we will provide the 
National Suicide Prevention Hotline call or text number (1-800-273-8255) to the 
subject or advise the subject to go to the nearest Emergency Department or call 
911. 
16.0
Potential Benefits to Subjects or Others
A strength of this proposal is that it will allow us to pivot in the directions of greatest need 
in one year with a multitude of potential therapeutic targets and benefits, once initial 
feasibility and efficacy of the taVNS home therapy protocol has been established. The 
research team is experienced and are leaders in neuromodulation research and are thus 
uniquely capable of successfully shepherding this pilot work into a funded clinical trial. 
Invasive cervical VNS is FDA approved for epilepsy and depression. Noninvasive cervical
VNS is FDA approved for cluster headaches. We have seen anxiolytic and 
antidepressant effects of taVNS. There is legitimate prospect of benefit for NeuroCovid 
symptoms although this is still experimental. All subjects will get the active open 
treatment for weeks 2-4. 
17.0
Sharing of Results with Subjects
There is no plan to inform subjects of the results of the study, but they can always contact
the research staff and ask. If there are significant new findings during the course of the 
study, they will be notified.
18.0
Devices 
Soterix, the device company, will ship the device to the RA’s at MUSC. The 
MUSC RA will then ship the device to the subject (along with a urine 
pregnancy test if that is indicated.) The subject is in charge of storing the 
device while it is at their house. The subject will be informed on how to 
manage and care for the device prior to receiving the device through a 
video. The study team will then hold training sessions with the subject. At 
the end of the 4 weeks the subject will need to ship the device back to 
MUSC with pre-paid packaging and a label. If the device is damaged at 
home, we will ship another device and have them ship the damaged unit 
back. Because the device can be remotely controlled, we will inform 
patients that the device becomes a ‘brick’ after the 4th week and has no 
resale value and cannot be used further. 
Importantly, the device is programmed remotely, and subjects cannot 
administer more than the indicated dose. That is, they cannot stimulate for 
more than the two one-hour sessions each day. If a subject falls asleep with
the device on it will turn itself off automatically. 

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We are asking for a Non-significant risk determination of this device. IRB 1 has 
consistently given NSR status for all prior taVNS studies at MUSC, 
including studies in stroke patients (Badran), brain damaged newborns 
learning to feed (Jenkins), Parkinson’s Disease (Hinson, Badran) and 
healthy volunteers (Badran). 

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