Vagal Nerve Stimulation for Post COVID Fatigue

Mayo Clinic

Status: Completed

Conditions: Post COVID Syndrome; Fatigue; Headache

Treatments: Device: vagal nerve stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT05445427

22-000925

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

VNS Treatment

Experimental group

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

Treatment:

Device: vagal nerve stimulator

Non-VNS Treatment

No Intervention group

Description:

Subjects with post COVID syndrome with fatigue and headache will receive current standard of care