Post COVID SyndromeNCT05445427
Vagal Nerve Stimulation for Post COVID Fatigue
A study testing vagal nerve stimulator in people with Post COVID Syndrome and Fatigue, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID Syndrome, Fatigue, Headache
- What is being tested?
- vagal nerve stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2022to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study
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.
Read the 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.
- Conditions
- Post COVID Syndrome, Fatigue, Headache
- Being tested
- vagal nerve stimulator
- Medical subject headings
- Fatigue, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagal nerve stimulatorDevice
Non-invasive vagus nerve stimulator
| Study group | Role | What they receive |
|---|---|---|
| VNS Treatment | Experimental | 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 Receives: Device: vagal nerve stimulator |
| Non-VNS Treatment | No intervention | Subjects with post COVID syndrome with fatigue and headache will receive current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-COVID Functional Status Score
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.
Measured: Baseline to 12 weeks
Secondary outcomes (1)
Change in PROMIS Fatigue Scale T Score
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start21 Dec 2022
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post COVID SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan T. Hurt, M.D., Ph.D., Mayo Clinic
- Investigators
- Ryan T. Hurt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445427
- Sponsor's protocol ID
- 22-000925
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2022
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Treatment With Vagal Nerve Stimulation in Post-COVID Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT05445427
- Acronym / sponsor ID
- 22-000925
- Conditions
- Post COVID Syndrome, Fatigue, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNS Treatment | Experimental | Device: vagal nerve stimulatorSubjects 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 |
| Non-VNS Treatment | No intervention | –Subjects with post COVID syndrome with fatigue and headache will receive current standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vagal nerve stimulatorNon-invasive vagus nerve stimulator | Device | VNS Treatment |
Primary outcome
Change in Post-COVID Functional Status Score
Time frame: 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.
1 secondary outcome
Change in PROMIS Fatigue Scale T Score
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Post COVID Syndrome
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
Long COVID
Active, not recruitingObservational study
Pain in Long COVID-19: The Role of Sleep
Long COVID
Recruiting
Effect of Hi-OxSR for the Treatment of Post COVID Condition
Long COVID, Post COVID-19 Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan T. Hurt, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vagal nerve stimulator in people with Post COVID Syndrome and Fatigue, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-COVID Functional Status Score (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.