NCT05445427

Vagal Nerve Stimulation for Post COVID Fatigue

Completed NA Results posted Last updated 12 March 2025

What this trial tests

NA trial testing vagal nerve stimulator in Post COVID Syndrome in 18 participants. Completed in 28 March 2024.

Timeline

21 December 2022

Primary endpoint
28 March 2024

28 March 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	21 December 2022
Primary completion	28 March 2024
Estimated completion	28 March 2024
Sites	1 location across United States

Drugs / interventions tested

• vagal nerve stimulator

Conditions studied

• Post COVID Syndrome — all drugs for Post COVID Syndrome →
• Fatigue — all drugs for Fatigue →
• Headache — all drugs for Headache →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Post COVID Syndrome or Fatigue. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Post-COVID Functional Status Score Primary · Baseline to 12 weeks

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.

Group	Value	95% CI
VNS Treatment	0.1	± 1.0
Non-VNS Treatment	0.3	± 0.7

Change in PROMIS Fatigue Scale T Score Secondary · Baseline to 12 weeks

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

Group	Value	95% CI
VNS Treatment	-5.4	± 11.6
Non-VNS Treatment	-1.9	± 4.7

Adverse events — posted to ClinicalTrials.gov

Time frame: During the 12 weeks of the study treatment period. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VNS Treatment

Serious: 0/8 (0%)

Deaths: 0/8

Non-VNS Treatment

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (2 terms — click to expand)

Reaction	System	VNS Treatment	Non-VNS Treatment
Nausea	Gastrointestinal disorders	—	—
Neck Tightness	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT05445427 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Detrimental effects of COVID-19 in the brain and therapeutic options for long COVID: The role of Epstein-Barr virus and the gut-brain axis.
   Hashimoto K. · · 2023 · cited 34× · PMID 37402856 · DOI 10.1038/s41380-023-02161-5
2. Exploring the Potential of Dietary Supplements to Alleviate Pain Due to Long COVID.
   Marchesi N, Allegri M, Bruno GM, Pascale A, et al · · 2025 · cited 2× · PMID 40219044 · DOI 10.3390/nu17071287