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.
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The Chalder Fatigue Questionnaire (CFQ)
Timeframe: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
Change in Short Form Health Survey (SF-36)
Timeframe: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
Visual Analog Scale (VAS) measuring Fatigue
Timeframe: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
VAS to measure Widespread Pain
Timeframe: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
VAS measuring Postexertional malaise (PEM)
Timeframe: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
VAS measuring brain fog
Timeframe: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
Global Clinical Assessment of Change
Timeframe: At 6 week (end of blinded phase) and at 12 weeks (end of open label phase)