TVNS in Long COVID-19

ID#: NCT06585254

Age: 21 - 70 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: September 01, 2024

End Date: December 31, 2026

Contact Information:
Patrick Quan
212-844-6665
Anna Norweg, PhD
212-844-6665
Summary: 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.
Eligibility:

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
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