Vagal Nerve Stimulation for Post COVID Fatigue

NCT ID: NCT05445427

Last Updated: 2025-03-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-21

Study Completion Date

2024-03-28

Brief Summary

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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

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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.

Conditions

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Post COVID Syndrome Fatigue Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

vagal nerve stimulator

Intervention Type DEVICE

Non-invasive vagus nerve stimulator

Non-VNS Treatment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vagal nerve stimulator

Non-invasive vagus nerve stimulator

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Ryan T. Hurt, M.D., Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan T. Hurt, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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22-000925

Identifier Type: -

Identifier Source: org_study_id

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