Transcutaneous vagus nerve stimulation for long COVID
Use of Transcutaneous Vagus Nerve Stimulation in Reducing the Symptoms of Long COVID Patients Who Fulfill Diagnostic Criteria for ME/CFS
This study is testing if a new device that stimulates the vagus nerve can help people with long COVID and chronic fatigue feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06585254 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of transcutaneous vagus nerve stimulation (tVNS) on patients suffering from long COVID and chronic fatigue syndrome. The study aims to compare two different sets of stimulation parameters to identify which one most effectively improves the health-related quality of life over a 6-week period. Participants will use the assigned device for at least 30 out of 42 opportunities, and those who respond positively will continue with the best device for an additional 6 weeks. The trial is motivated by the need for effective treatments for post-acute sequelae of SARS-CoV-2 infection, as current options are limited.
Who should consider this trial
Good fit: Ideal candidates are individuals who have had a documented COVID-19 infection and meet the criteria for chronic fatigue syndrome.
Not a fit: Patients who are severely obese (BMI ≥30), hospitalized for COVID-19, or pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from long COVID and chronic fatigue syndrome.
How similar studies have performed: Previous open-label studies have shown promising results for tVNS in similar patient populations, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * BMI ≥30 * Hospitalized for COVID-19 infection * BMI ≥30 * Pregnancy
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin H Natelson, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Patrick Quan
- Email: Patrick.quan@mssm.edu
- Phone: 212-844-6665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.