Vagal Nerve Stimulation for Post COVID Fatigue

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05445427
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post COVID Syndrome; Fatigue; Headache	Device: vagal nerve stimulator	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 that assesses COVID-19 symptom impact on a grading scale of 0= no limitations to 4= severe limitations.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Ravindra Ganesh, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Ravindra Ganesh, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05445427
• Other Study ID Numbers: 22-000925
• First Posted: Jul 6, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• 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
• Additional relevant MeSH terms: Syndrome; Fatigue; Headache

Study Results

No Results Posted as of Aug 1, 2022