tVNS in Long COVID-19
NCT Number: NCT06585254
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Long Covid Also Fulfilling Criteria for Chronic Fatigue Syndrome
Interventions: DEVICE: Transcutaneous vagus nerve stimulator
Sponsor: Icahn School of Medicine at Mount Sinai
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12-31
Locations: Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States

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.

Primary Outcome Measures: The Chalder Fatigue Questionnaire (CFQ), The Chalder Fatigue Questionnaire (CFQ) is used as a measure of fatigue. The CFQ consists of 11 items and uses likert scoring 0, 1, 2, 3, providing a full scale range of 0-33, where lowest score is least fatigue., End of 6 week|Change in Short Form Health Survey (SF-36), The SF-36 is a multi-purpose, short form health survey consisting of 36 questions. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. SF-36 will be assessed for physical function score improved from baseline by 0.6 SD or 14%., baseline and End of 6 week blinded phase|Visual Analog Scale (VAS) measuring Fatigue, Participants will be asked to mark the level of their fatigue along the line.of 0 (no fatigue) to 10 (Worst fatigue imaginable). Full scale from 0-10 with higher score indicating poorer health outcome., End of 6 week blinded phase|VAS to measure Widespread Pain, Participants will be asked to mark the level of their bodywide pain along the line.of "no bodywide pain" to "Worst bodywide pain imaginable". Full scale from 0-10 with higher score indicating poorer health outcome., End of 6 week blinded phase|VAS measuring Postexertional malaise (PEM), Participants will be asked to mark the level of their PEM along the line of "no PEM" to "Worst PEM imaginable". Full scale from 0-10 with higher score indicating poorer health outcome., End of 6 week blinded phase|VAS measuring brain fog, Participants will be asked to mark the level of their brain fog along the line of "no brain fog" to "Worst brain fog imaginable". Full scale from 0-10 with higher score indicating poorer health outcome., End of 6 week blinded phase|Global Clinical Assessment of Change, Global Clinical Assessment of Change --+3 or +2 on a scale ranging from +3 \[very much improved\] thru 0 \[no change\] to -3 \[very much worse\], End of 6 week blinded phase
Secondary Outcome Measures: Heart Rate Variability, Participants will attach a device invented by the co-investigator which detects ECG and can quantify R-R intervals compute root mean square of successive differences (RMSSD) between normal heartbeats. The RMSSD reflects the beat-to-beat variance in heart rate and is the primary time-domain measure used to estimate the vagally mediated changes reflected in HR., End of 6 week blinded phase