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OpenTrials
Completed

NCT Number: NCT05445427

Vagal Nerve Stimulation for Post COVID Fatigue

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.

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Key information

Conditions

Post COVID Syndrome Fatigue Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of fatigue and post exertional malaise.
  • Presence of headache
  • Clinical diagnosis of post COVID syndrome.
  • They have consented to participate in the study
  • They have the ability to participate in all aspects of the study.

Exclusion criteria

  • Pregnant.
  • Prior adverse reaction to 14FDG.
  • Active implantable medical device e.g. pacemaker, hearing aid implant
  • Metallic device e.g. stent, orthopedic hardware in neck
  • Using another electronic device at the same time e.g. TENS, mobile phone.
  • Any other condition deemed exclusionary by the study principal investigator

Treatment and study plan

Vagal Nerve Stimulator

Device

Non-invasive vagus nerve stimulator

Primary outcomes

  1. Change in Post-COVID Functional Status Score

    Time frame: 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.

Secondary outcomes

  1. Change in PROMIS Fatigue Scale T Score

    Time frame: 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 a worse outcome.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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