tVNS in Long COVID-19
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
50 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- BMI ≥30
- Hospitalized for COVID-19 infection
- BMI ≥30
- Pregnancy
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
A device attached to the tragus of the ear which when activated stimulates an ascending branch of the vagus nerve
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06585254