Use of Transcutaneous Vagus Nerve Stimulation in Reducing the Symptoms of Long COVID Patients Who Fulfill Diagnostic Criteria for ME/CFS
Icahn School of Medicine at Mount Sinai
Summary
A prior open label study has shown that transcutaneous vagus nerve stimulation \[tVNS\] can improve the health of some patients with postacute sequelae of SARS-CoV-2 infection (PASC), severely affected enough to also fulfill criteria for myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). The purpose of this study is to compare two sets of stimulus parameters to determine the one that best improves the health-related quality of life of these patients over a period of 6-weeks. Patients using their assigned device for at least 30 of the 42 possible opportunities will receive the best device for an additional 6-week period.
Description
While the US has officially said the SARS CoV-2 emergency is over, the country is left with a residual of patients who continue to experience Post-Acute Sequelae of SARS CoV-2 infection -- PASC. Unfortunately, despite a major effort to understand PASC via the NIH Researching Covid to Enhance Recovery program, no specific treatment has emerged and only a limited number of new trials has been initiated. The purpose of this proposal is to perform a clinical trial of noninvasive, transcutaneous vagus nerve stimulation \[tVNS\] in an attempt to find the best tVNS treatment for these patients. The…
Eligibility
- Age range
- 21–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Must have had documented Covid infection and then fulfill 2015 case definition for ME/CFS * Chalder Fatigue Scale score of 4 or greater * SF-36 Physical Function scale score ≤70 * VAS values of 3 or higher from 0 \[none\] 3 \[substantial\] to 5 \[very severe burden\] on at least two of the following symptoms - fatigue; widespread pain, brain fog, post-exertional malaise Exclusion Criteria: * BMI ≥30 * Hospitalized for COVID-19 infection * BMI ≥30 * Pregnancy
Interventions
- DeviceTranscutaneous vagus nerve stimulator
A device attached to the tragus of the ear which when activated stimulates an ascending branch of the vagus nerve
Location
- Icahn School of Medicine at Mount SinaiNew York, New York