Back to search results
NCT06585254

tVNS in Long COVID-19

Active, Not Recruiting
NAAges 21–70InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~50 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Transcutaneous vagus nerve stimulator

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Chalder Fatigue Questionnaire (CFQ)
Measured over Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)
+6 more outcomes measured

Conditions

Long COVID
Chronic Fatigue Syndrome

Explore related trials

Chronic Fatigue SyndromePost-Acute Sequelae of COVID-19

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Benjamin H Natelson, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Anna Norweg, PhD · STUDY_DIRECTOR · Icahn School of Medicine at Mount Sinai

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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

What this trial measures

  • The Chalder Fatigue Questionnaire (CFQ)Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)

    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.

  • Change in Short Form Health Survey (SF-36)Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)

    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%.

  • Visual Analog Scale (VAS) measuring FatigueBaseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)

    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.

  • VAS to measure Widespread PainBaseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)

    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.

  • VAS measuring Postexertional malaise (PEM)Baseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)

    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.

  • VAS measuring brain fogBaseline, at 6 week (end of blinded phase), and at 12 weeks (end of open label phase)

    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.

  • Global Clinical Assessment of ChangeAt 6 week (end of blinded phase) and at 12 weeks (end of open label phase)

    Global Clinical Assessment of Change --+3 or +2 on a scale ranging from +3 \[very much improved\] thru 0 \[no change\] to -3 \[very much worse\]