Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study
Overview
- Phase
- N/A
- Intervention
- vagal nerve stimulator
- Conditions
- Post COVID Syndrome
- Sponsor
- Mayo Clinic
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Change in Post-COVID Functional Status Score
- Status
- Completed
- Last Updated
- 8 days ago
Overview
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.
Detailed Description
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.
Investigators
Ryan T. Hurt, M.D., Ph.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
Arms & Interventions
VNS Treatment
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
Intervention: vagal nerve stimulator
Non-VNS Treatment
Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
Outcomes
Primary Outcomes
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
- Change in PROMIS Fatigue Scale T Score(Baseline to 12 weeks)