An interventional study of vagal nerve stimulator in Post COVID Syndrome, Fatigue and Headache, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the impact of vagal nerve stimulation on patients with post COVID syndrome who have fatigue and headache.
Patients, after consenting, will perform questionnaires, have a blood samples taken, and undergo PET/CT scans of the brain. Patients will then be randomized to either receive vagal nerve stimulation, or continue standard clinical care. For those randomized to receive treatment, they will be given a device and asked to follow a specific regimen daily for 12 weeks.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 18 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects with post COVID syndrome with fatigue and headache will have vagal nerve stimulator applied to the neck for 2 minute intervals with two sets administered three times daily
Device: vagal nerve stimulator
Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
Non-invasive vagus nerve stimulator
Change in Post-COVID Functional Status Score
Measurement is the change in scoring determined through patients' self-reported Post-COVID Functional Status Score survey, which assesses COVID-19 symptom impact on a grading scale of 0 = no limitations to 4 = severe limitations. Thus, higher scores are a worse outcome, and a change indicating an increase is a worsening of functional status.
Time frame: Baseline to 12 weeks
Change in PROMIS Fatigue Scale T Score
Measurement is the change in score determined through patients' self-reported PROMIS Short Form v1.0 - Fatigue 7a. The PROMIS Fatigue Scale assesses 7 items on a scale of 1 (never) to 5 (always). Scale scores were converted to T scores using the published guidelines. A T-score of 50 is the average for the general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS Fatigue T-score represents more of the concept being measured; thus, an increase in fatigue T score corresponds to more fatigue - which is a worse outcome.
Time frame: Baseline to 12 weeks
Between 12/19/2022 and 03/06/2024, a total of 18 Long Covid patients were found to be eligible to participate in this study through a Long Covid Clinic at a single medical center.
| Milestone | VNS Treatment | Non-VNS Treatment |
|---|---|---|
| Started | 8 | 10 |
| Completed | 8 | 10 |
| Not completed | 0 | 0 |
Measurement is the change in scoring determined through patients' self-reported Post-COVID Functional Status Score survey, which assesses COVID-19 symptom impact on a grading scale of 0 = no limitations to 4 = severe limitations. Thus, higher scores are a worse outcome, and a change indicating an increase is a worsening of functional status.
| units on a scale | VNS Treatment | Non-VNS Treatment |
|---|---|---|
| Change in Post-COVID Functional Status Score | 0.1 ± 1.0 | 0.3 ± 0.7 |
Measurement is the change in score determined through patients' self-reported PROMIS Short Form v1.0 - Fatigue 7a. The PROMIS Fatigue Scale assesses 7 items on a scale of 1 (never) to 5 (always). Scale scores were converted to T scores using the published guidelines. A T-score of 50 is the average for the general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS Fatigue T-score represents more of the concept being measured; thus, an increase in fatigue T score corresponds to more fatigue - which is a worse outcome.
| units on a scale | VNS Treatment | Non-VNS Treatment |
|---|---|---|
| Change in PROMIS Fatigue Scale T Score | -5.4 ± 11.6 | -1.9 ± 4.7 |
Collected over During the 12 weeks of the study treatment period. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VNS Treatment | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Non-VNS Treatment | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Event | VNS Treatment | Non-VNS Treatment |
|---|---|---|
| NauseaGastrointestinal disorders | 1/8 | 0/10 |
| Neck TightnessMusculoskeletal and connective tissue disorders | 1/8 | 0/10 |
| Age, Continuous(years) | VNS Treatment | Non-VNS Treatment | Total |
|---|---|---|---|
| Mean | 46.3 ± 10.8 | 46.9 ± 14.7 | 46.6 ± 12.8 |
| Sex: Female, Male(Participants) | VNS Treatment | Non-VNS Treatment | Total |
|---|---|---|---|
| Female | 5 | 7 | 12 |
| Male | 3 | 3 | 6 |
| Race/Ethnicity, Customized(Participants) | VNS Treatment | Non-VNS Treatment | Total |
|---|---|---|---|
| NonHispanic/White | 8 | 9 | 17 |
| Hispanic/White | 0 | 1 | 1 |
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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