TVNS in Long COVID-19

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.

Conditions

Long COVID, Chronic Fatigue Syndrome

Study Overview

Study Details

Study overview

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.

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

TVNS in Long COVID-19

Condition
Long COVID
Intervention / Treatment

-

Contacts and Locations

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * BMI ≥30
  • * Hospitalized for COVID-19 infection
  • * BMI ≥30
  • * Pregnancy

Ages Eligible for Study

21 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Benjamin H Natelson, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Anna Norweg, PhD, STUDY_DIRECTOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2026-12-31