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Device

Vagal Nerve Stimulation for Post-COVID Syndrome

N/A
Recruiting
Led By Ravindra Ganesh
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of headache
Clinical diagnosis of post COVID syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights

Study Summary

This trial will test if a device that sends electrical signals to the vagus nerve can help improve symptoms in people who have fatigue and headaches after contracting COVID-19.

Who is the study for?
This trial is for individuals who have been diagnosed with post COVID syndrome and are experiencing persistent fatigue, headaches, and post exertional malaise. Participants must be able to engage in all study activities. Those with metallic neck devices, active implants like pacemakers or hearing aids, pregnancy, prior adverse reactions to 14FDG, or using other electronic devices simultaneously are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a vagal nerve stimulator on alleviating symptoms of fatigue and headache in patients suffering from post COVID syndrome. The goal is to see if this treatment can improve their condition.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, voice changes due to nerve activation, tingling sensations or muscle twitching near the neck area where the device operates.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience headaches.
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I have been diagnosed with long COVID.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Post-COVID Functional Status Score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: VNS TreatmentExperimental Treatment1 Intervention
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 II: Non-VNS TreatmentActive Control1 Intervention
Subjects with post COVID syndrome with fatigue and headache will receive current standard of care

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,764 Total Patients Enrolled
Ravindra GaneshPrincipal InvestigatorMayo Clinic

Media Library

Vagal Nerve Stimulator (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05445427 — N/A
Post-COVID Syndrome Research Study Groups: VNS Treatment, Non-VNS Treatment
Post-COVID Syndrome Clinical Trial 2023: Vagal Nerve Stimulator Highlights & Side Effects. Trial Name: NCT05445427 — N/A
Vagal Nerve Stimulator (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445427 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this experiment still possible for those who meet the criteria?

"This clinical trial is not currently accepting new candidates; however, its listing on clinicialtrials.gov specifies that it was initially posted in October 1st 2022 and last updated four days later. There are still 1723 other trials seeking participants at this time."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Vagal Nerve Stimulation for Post COVID Fatigue
Ravindra Ganesh 2022. "Vagal Nerve Stimulation for Post COVID Fatigue". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445427.
All > Headache
~2 spots leftby Jul 2024
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