tVNS in Long COVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
BMI ≥30
Hospitalized for COVID-19 infection
BMI ≥30
Pregnancy
Trial design
Treatments tested in this trial
- Transcutaneous vagus nerve stimulator
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov