Status:
RECRUITING
tVNS in Long COVID-19
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Long COVID
Chronic Fatigue Syndrome
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief 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 affecte...
Detailed Description
While the US has officially said the SARS CoV-2 emergency is over, the country is left with a residual of patients who continue to experience Post-Acute Sequelae of SARS CoV-2 infection -- PASC. Unfor...
Eligibility Criteria
Inclusion
- 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
- BMI ≥30
- Hospitalized for COVID-19 infection
- BMI ≥30
- Pregnancy
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06585254
Start Date
November 1 2024
End Date
December 31 2026
Last Update
August 8 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029