NCT06585254 · Icahn School of Medicine at Mount Sinai
tVNS in Long COVID-19
What this study 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).
View original scientific description
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.
Interventions
DEVICE
Transcutaneous vagus nerve stimulator
A device attached to the tragus of the ear which when activated stimulates an ascending branch of the vagus nerve
Primary outcome measures
The Chalder Fatigue Questionnaire (CFQ)
Time frame: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
The Chalder Fatigue Questionnaire (CFQ) is used as a measure of fatigue. The CFQ consists of 11 items and uses likert scoring 0, 1, 2, 3, providing a full scale range of 0-33, where lowest score is least fatigue.
Change in Short Form Health Survey (SF-36)
Time frame: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. SF-36 will be assessed for physical function score improved from baseline by 0.6 SD or 14%.
Visual Analog Scale (VAS) measuring Fatigue
Time frame: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
VAS total scale from 0-5 scoring system \[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\]. Higher score indicates poorer health outcome.
VAS to measure Widespread Pain
Time frame: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
VAS total scale from 0-5 scoring system \[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\]. Higher score indicates poorer health outcome.
VAS measuring Postexertional malaise (PEM)
Time frame: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
VAS total scale from 0-5 scoring system \[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\]. Higher score indicates poorer health outcome.
VAS measuring brain fog
Time frame: Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
VAS total scale from 0-5 scoring system \[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\]. Higher score indicates poorer health outcome.
Global Clinical Assessment of Change
Time frame: At 6 week (end of blinded phase) and at 12 weeks (end of open label phase)
Global Clinical Assessment of Change --+3 or +2 on a scale ranging from +3 \[very much improved\] thru 0 \[no change\] to -3 \[very much worse\]
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Hospitalized for COVID-19 infection
Where
- New York, New York
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 8, 2025 · Source of record for eligibility and locations