Recruiting

Transcutaneous Vagus Nerve Stimulation for Long COVID with ME/CFS Symptoms

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What is being tested

Transcutaneous vagus nerve stimulator

Device
Who is being recruted

COVID-19+22

+ Neuroinflammatory Diseases

+ Post-Acute COVID-19 Syndrome

From 21 to 70 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorIcahn School of Medicine at Mount Sinai
Study ContactPatrick QuanMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on finding an effective treatment for people experiencing long-term symptoms after recovering from COVID-19, specifically those who also show signs of Chronic Fatigue Syndrome (CFS). Many people continue to suffer from symptoms like fatigue, widespread pain, and cognitive issues long after their initial infection. This study aims to test a noninvasive method called transcutaneous vagus nerve stimulation (tVNS), which involves using a device to stimulate a nerve in the neck. The goal is to determine the best way to use this treatment to alleviate the symptoms in people with both Post-Acute Sequelae of SARS CoV-2 infection (PASC) and CFS. Participants in the study will be divided into two groups to test different methods of using the tVNS device. They will use the device for 35 minutes each morning over a six-week period, without needing to visit a medical center. During the fifth week, participants will use a stick-on device to measure heart rate variability, which helps assess how well the treatment is working. They will also fill out questionnaires about their symptoms and overall health. After six weeks, they will return the device and complete another set of questionnaires. Those who use the device as instructed may continue the treatment for an additional six weeks if it shows positive results. This approach allows researchers to gather data remotely and potentially offer relief to those suffering from the lingering effects of COVID-19 and CFS.

Official TitleUse of Transcutaneous Vagus Nerve Stimulation in Reducing the Symptoms of Long COVID Patients Who Fulfill Diagnostic Criteria for ME/CFS
NCT06585254
Principal SponsorIcahn School of Medicine at Mount Sinai
Study ContactPatrick QuanMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Neuroinflammatory DiseasesPost-Acute COVID-19 SyndromePost-Infectious DisordersChronic DiseaseCoronaviridae InfectionsEncephalomyelitisInfectionsLung DiseasesMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeuromuscular DiseasesPathologic ProcessesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsPathological Conditions, Signs and SymptomsVirus DiseasesFatigue Syndrome, ChronicCoronavirus InfectionsDisease AttributesNidovirales Infections

Criteria

4 inclusion criteria required to participate
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
4 exclusion criteria prevent from participating
BMI ≥30
Hospitalized for COVID-19 infection
BMI ≥30
Pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patient will ramp up current intensity until uncomfortable, then ratchet back to what is comfortable and press button. Patient is to do this daily for 35 minutes for 6 weeks.

Group II

Experimental
Patients will ramp up current intensity until uncomfortable, then ratchet back to what is comfortable and press button. The device has software embedded in it that is used to arrive at a personalized way of stimulating the vagus nerve. At this level, the device stimulus will not be sensed by the patient. Patient is to do this daily for 35 minutes for 6 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Icahn School of Medicine at Mount Sinai

New York, United StatesOpen Icahn School of Medicine at Mount Sinai in Google Maps
Recruiting
One Study Center