Vagal Nerve Stimulation for Post COVID Fatigue

Not Applicable

Completed

• Conditions: Post COVID Syndrome; Headache; Fatigue
• Interventions: Device: vagal nerve stimulator

• Registration Number: NCT05445427
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-06
• Study Start: 2022-12-21
• Primary Completion: 2024-03-28
• Study Completion: 2024-03-28
• Results First Submitted: 2025-02-25
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Results First Posted: 2025-03-12
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VNS Treatment	vagal nerve stimulator	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

Primary Outcome Measures

Name	Time	Method
Change in Post-COVID Functional Status Score	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 Outcome Measures

Name	Time	Method
Change in PROMIS Fatigue Scale T Score	Baseline to 12 weeks	Measurement is the change in score determined through patients' self-reported PROMIS Short Form v1.0 - Fatigue 7a. The PROMIS Fatigue Scale assesses 7 items on a scale of 1 (never) to 5 (always). Scale scores were converted to T scores using the published guidelines. A T-score of 50 is the average for the general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS Fatigue T-score represents more of the concept being measured; thus, an increase in fatigue T score corresponds to more fatigue - which is a worse outcome.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States