Actively Recruiting
tVNS in Long COVID-19
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-08-08
50
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
tVNS in Long COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have had documented Covid infection and fulfill 2015 case definition for ME/CFS
- Chalder Fatigue Scale score of 4 or greater
- SF-36 Physical Function scale score less than 70
- VAS score of 3 or higher on at least two symptoms among fatigue, widespread pain, brain fog, or post-exertional malaise
You will not qualify if you...
- Body mass index (BMI) of 30 or higher
- Hospitalized for COVID-19 infection
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
P
Patrick Quan
CONTACT
A
Anna Norweg, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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