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NCT05445427 Clinical Trial

Vagal Nerve Stimulation for Post COVID Fatigue

Fatigue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05445427
Other study ID # 22-000925
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 21, 2022
Est. completion date March 28, 2024

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date March 28, 2024
Est. primary completion date March 28, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• vagal nerve stimulator
Non-invasive vagus nerve stimulator

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline to 12 weeks
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