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.
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)