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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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
  • Device: vagal nerve stimulator
    Non-invasive vagus nerve stimulator
No Intervention
Non-VNS Treatment 		Subjects with post COVID syndrome with fatigue and headache will receive current standard of care

Recruiting Locations

More Details

NCT ID
NCT05445427
Status
Completed
Sponsor
Mayo Clinic

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.