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Device

Vagus Nerve Stimulation for Post-COVID Syndrome

N/A
Recruiting
Led By Benjamin H Natelson, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have had documented Covid infection and then fulfill 2015 case definition for ME/CFS
SF-36 Physical Function scale score ≤70
Must not have
Hospitalized for COVID-19 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of 6 week
Awards & highlights

Summary

This trial aims to compare different settings of vagus nerve stimulation to see which one improves the quality of life for patients with long-term COVID symptoms and chronic fatigue syndrome. Patients who use the device regularly will

Who is the study for?
This trial is for individuals who had COVID-19 and now meet the criteria for chronic fatigue syndrome (ME/CFS). They should experience significant fatigue, pain, brain fog, or worsening symptoms after exertion. It's not suitable for those who were hospitalized due to COVID-19, are pregnant, or have a BMI of 30 or more.
What is being tested?
The study tests a non-invasive device called transcutaneous vagus nerve stimulator (tVNS) on patients with long-term COVID-19 effects. It aims to find out which stimulation settings improve quality of life over six weeks by comparing two different parameter sets.
What are the potential side effects?
While specific side effects aren't detailed here, tVNS can sometimes cause headache, dizziness or skin irritation where it's applied. Side effects vary from person to person based on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had COVID-19 and now meet the criteria for chronic fatigue syndrome.
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My physical health limits my daily activities.
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I experience significant fatigue, pain, brain fog, or post-exertional malaise.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am hospitalized due to COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of 6 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of 6 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Short Form Health Survey (SF-36)
Global Clinical Assessment of Change
The Chalder Fatigue Questionnaire (CFQ)
+4 more
Secondary study objectives
Heart Rate Variability

Trial Design

2Treatment groups
Experimental Treatment
Group I: Patient controlledExperimental Treatment1 Intervention
Patient will ramp up 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: AI ControlledExperimental Treatment1 Intervention
Patients will ramp up current until uncomfortable, then ratchet down to what is comfortable and then press button. An AI paradigm will use data generated by the patient and device to arrive at a set of stimulus parameters that will not be sensible to the patient. Patient is to do this daily for 35 minutes for 6 weeks.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
886 Previous Clinical Trials
534,993 Total Patients Enrolled
Benjamin H Natelson, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
64 Total Patients Enrolled
Anna Norweg, PhDStudy DirectorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
4 Total Patients Enrolled
~33 spots leftby Dec 2026
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