Back to resultsVagal Nerve Stimulation for Post COVID Fatigue
Primary Purpose
Post COVID Syndrome, Fatigue, Headache
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vagal nerve stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Post COVID Syndrome
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
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
VNS Treatment
Non-VNS Treatment
Arm Description
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
Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
Outcomes
Primary Outcome Measures
Change in Post-COVID Functional Status Score
Measurement is the change in scoring determined through patients self-reported Post-COVID Functional Status Score survey that assesses COVID-19 symptom impact on a grading scale of 0= no limitations to 4= severe limitations.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05445427
Brief Title
Vagal Nerve Stimulation for Post COVID Fatigue
Official Title
Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post COVID Syndrome, Fatigue, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VNS Treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Non-VNS Treatment
Arm Type
No Intervention
Arm Description
Subjects with post COVID syndrome with fatigue and headache will receive current standard of care
Intervention Type
Device
Intervention Name(s)
vagal nerve stimulator
Intervention Description
Non-invasive vagus nerve stimulator
Primary Outcome Measure Information:
Title
Change in Post-COVID Functional Status Score
Description
Measurement is the change in scoring determined through patients self-reported Post-COVID Functional Status Score survey that assesses COVID-19 symptom impact on a grading scale of 0= no limitations to 4= severe limitations.
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravindra Ganesh
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hanson
Phone
507-255-6205
Email
postcovidrsch@mayo.edu
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Vagal Nerve Stimulation for Post COVID Fatigue
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