tVNS in Long COVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-70
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
BMI ≥30
Hospitalized for COVID-19 infection
BMI ≥30
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous vagus nerve stimulator
DeviceA device attached to the tragus of the ear which when activated stimulates an ascending branch of the vagus nerve
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: #1: Patient controlledExperimental treatment 1 intervention
Group B: #2: Device ControlledExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)2
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%.
Time frame
Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)3
Visual Analog Scale (VAS) measuring Fatigue
VAS total scale from 0-5 scoring system \[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\]. Higher score indicates poorer health outcome.
Time frame
Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)4
VAS to measure Widespread Pain
VAS total scale from 0-5 scoring system \[0 none; 1 mild; 2 moderate; 3 substantial; 4 severe; 5 very severe\]. Higher score indicates poorer health outcome.
Time frame
Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)Secondary outcomes
1
Heart Rate Variability (HRV)
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 heart rate (HR).
Time frame
Baseline and at 5-6 week (end of blinded phase)Sponsors and contacts
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Source ClinicalTrials.gov