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tVNS in Long COVID-19

Key facts

Where
New York, Egyesült ÁllamokSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 21 and 70 years old?

Where in Egyesült Államok

  • Icahn School of Medicine at Mount SinaiNew York, Egyesült ÁllamokNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Icahn School of Medicine at Mount Sinai
Trial code
NCT06585254
Record updated
2026. augusztus 3.
Original 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.Read full original descriptionShow less

Use of Transcutaneous Vagus Nerve Stimulation in Reducing the Symptoms of Long COVID Patients Who Fulfill Diagnostic Criteria for ME/CFS

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.

Inclusion: 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: Hospitalized for COVID-19 infection; BMI ≥30; BMI ≥30; Pregnancy.

ClinicalTrials.gov NCT06585254