tVNS in Long COVID-19

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called transcutaneous vagus nerve stimulation (tVNS) for patients experiencing long-term symptoms after COVID-19, known as Long COVID, as well as those with chronic fatigue syndrome (CFS). Researchers want to find out which of two different settings for the tVNS device works best to improve the quality of life for these patients over a 6-week period. In simpler terms, this study aims to see if using this device can help relieve symptoms like fatigue, pain, and brain fog that many people face after recovering from COVID-19.

To be eligible for this study, participants must have had a documented COVID-19 infection and meet specific criteria for chronic fatigue syndrome, such as a certain level of fatigue and limitations in physical function. The trial is open to adults aged 18 and older, and it’s important to note that those with a higher body mass index (BMI), who were hospitalized for COVID-19, or who are pregnant cannot participate. Participants will use the assigned device for about 30 out of 42 possible sessions, and those who complete this will receive the most effective device for an additional 6 weeks. If you're interested and meet the criteria, this trial could provide a chance to explore a potential new way to manage your symptoms.

Gender

ALL

Eligibility 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