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Sponsor: Icahn School of Medicine at Mount Sinai
Conditions: Long COVID, Chronic Fatigue Syndrome
Interventions: Transcutaneous vagus nerve stimulator
Countries: United States
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.
Sex: ALL
Age: 21 Years to 70 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- New York, New York, United States