Vagal Nerve Stimulation for Post COVID Fatigue
Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
December 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2024
CompletedResults Posted
Study results publicly available
March 12, 2025
CompletedApril 24, 2026
April 1, 2026
1.3 years
July 1, 2022
February 25, 2025
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline to 12 weeks
Secondary Outcomes (1)
Change in PROMIS Fatigue Scale T Score
Baseline to 12 weeks
Study Arms (2)
VNS Treatment
EXPERIMENTALSubjects 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
Non-VNS Treatment
NO INTERVENTIONSubjects with post COVID syndrome with fatigue and headache will receive current standard of care
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ryan T. Hurt, MD, PhD
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan T. Hurt, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 1, 2022
First Posted
July 6, 2022
Study Start
December 21, 2022
Primary Completion
March 28, 2024
Study Completion
March 28, 2024
Last Updated
April 24, 2026
Results First Posted
March 12, 2025
Record last verified: 2026-04