Brief Study Description
As our understanding of coronavirus 2 (SARS-CoV-2) and the mechanisms involved in developing acute coronavirus disease 2019 (COVID-19) expand, there is a growing number of clinical cases of COVID-19 with chronic symptoms who are presently referred to as COVID long-haulers.
COVID-19 illness involves other body organs besides the lungs. In recovered patients, chronic symptoms may include dysautonomia, fatigue, “brain fog,” abdominal pain, bloating, gastroparesis, and nausea, headache, arthralgia, myalgia and sleep disturbance. Chronic depression and anxiety are also common.
Dysautonomia itself can contribute to cardiac symptoms that include chest pain, palpitations, exercise intolerance, and orthostatic intolerance.
Our premise is that the chronic inflammation associate with COVID-19 illness is a contributing factor to the dysautonomia experienced by long-haulers. Transcutaneous vagus nerve stimulation is capable of reduce of pro-inflammatory cytokines and improve clinical outcome in a variety of medical conditions including inflammatory bowel disease, rheumatoid arthritis and sepsis.
Our study will evaluate autonomic nervous system function through a symptom survey and advanced spectral analysis. Spectral analysis is pain less and involves interpretation of autonomic signals obtained from a simple electrocardiogram.
If evidence of autonomic dysfunction is found, the study subjects will be offered treatment with daily, at home, transcutaneous vagus nerve stimulation (tVNS). tVNS is operated through an iPhone or Android smartphone, is painless, safe and require only 3 5-minute treatments per day. Repeat symptom survey and spectral analysis testing will be performed in 4 weeks.
Study involves assessing patients for autonomic dysfunction with both a survey and spectral analysis. Those demonstrating evidence of autonomic dysfunction will be offered treatment with transcutaneous vagus nerve stimulation using the Vitality Smart Cable.
Patients will self-administer 3, 5-minute treatments per day for 4 weeks. After which time they will return to the office for re-evaluation with the same survey and spectral analysis.
Number of Subjects for Pilot Trial
- 10 subjects will be evaluated and will be assessed in 2 groups of 5. Enrollment might be expanded if there is evidence of efficacy.
- Inclusion and exclusion criteria are listed below.
Cost to Patient
The study and use of vagus nerve stimulator will be performed at no cost to the patient. Other costs such as transportation or housing if traveling from outside of the Arizona area will not be reimbursed.
- Group 1 – March 5th and April 2nd
- Group 2 – March 19th and April 16th
Visit #1 Components
- Obtain Consent
- Perform Survey
- Autonomic spectral analysis testing
- Instructions on use of Vitality Smart Cable
- Scheduling for 2nd visit
Visit #2 Components
- Repeat Survey
- Autonomic spectral analysis testing
- Return of Vitality Smart Cable
- Enrollment in long term follow-on study
- Male or female adult ≥ 18 years of age at time of enrollment.
- Patient with prior confirmed COVID-19 diagnosis by standard RT-PCR assay or equivalent testing.
- Currently experiencing two or more of the following symptoms consistent with COVID-19 infection for a prolonged period of time (>8 weeks).
- Respiratory symptoms such as cough, sore throat, stuffy or runny nose, shortness of breath (difficulty breathing), tightness of chest etc.
- Neurological symptoms such as difficulty in concentration (brain fog), sleep disturbance/insomnia, headache, dizziness, anxiety, tingling or numbness, loss of sense of smell or taste etc.
- Cardiovascular and Gastrointestinal symptoms such as feeling of fast heartbeat, nausea, vomiting, diarrhea, etc.
- General immune response symptoms such as fatigue (low energy or tiredness), muscle cramps or joint pain.
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Subject must have an Android or iPhone smartphone, iPad or iPod in order to receive treatment vagus nerve stimulation.
- Known intolerance to vagus nerve stimulation
- Recurrent fever
- No history of Chronic Fatigue Syndrome prior to COVID-19 infection
- No history of fibromyalgia prior to COVID-19 infection
- Diagnosis of malignant tumor, or other serious systemic diseases
Enrollment is expected to begin within the next week.