Post COVID-19 ConditionNCT06865222
Post COVID-19 Syndrome Treatment With Variable Pulse Transcranial Magnetic Stimulation
A study testing Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks and Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks in people with Post COVID-19 Condition, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test if Variable Pulse TMS (Transcranial Magnetic Stimulation) can result in objective improvements in patients with Post COVID Syndrome (PCS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post COVID-19 Condition
- What is being tested?
- Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks and Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have had a recent episode of COVID-19 and who present to the Post COVID-19 Clinic at Mayo Clinic Rochester with at least one of the PCC symptoms of interest - anosmia, tinnitus, fatigue. Symptoms consistent with PCC lasting at least 1 month after the positive test date. Subjects must have ongoing symptoms for > 4 weeks following the start of an acute covid infection. This is consistent with the CDC definition for post covid conditions. Start date is determined by date of first positive COVID test. There is no limitation of maximum time from acute infection start.
- At least one of the PCC symptoms of interest:
- Anosmia: Olfactory Threshold Test scores corresponding to Anosmia or Hyposmia
- Tinnitus: >0 score on Tinnitus Handicap Inventory (not present prior to SARS-COVID 2 infection)
- Fatigue: Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above
Who cannot join
- Implanted electronic devices, including pacemakers, defibrillators, implant medication pumps, or vagus nerve stimulators (VNS)
- Active alcohol abuse: >14 drinks a week or formal diagnosis, illicit drug use or drug abuse
- Any seizure history within the past 10 years
- Intracranial implant within 30 cm of magnet (e.g., aneurysm clips, endovascular coil, cerebral shunts, brain stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
- Enrolled or plans to enroll in an interventional trial during this study
- Previous stroke with residual deficits
Show all 12Show fewer
- Subjects unable to comprehend or follow verbal commands
- Subjects unable to comprehend and sign the informed consent
- Based on PI's or local physician's assessment that subject unable to tolerate the trial procedure due to medical condition
- Clinical abnormality or clinically unstable medical condition, as indicated by medical history, physical examination, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results
- Pregnant or trying to become pregnant; negative urine pregnancy test at screening will be required for females of childbearing potential
- Any condition which in the judgment of the investigator would prevent the subject from completion of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Ryan T. Hurt
About this study
Official title: Variable Pulse Transcranial Magnetic Stimulation for Treatment of Post COVID Syndrome
The purpose of this study is to test if Variable Pulse TMS (Transcranial Magnetic Stimulation) can result in objective improvements in patients with Post COVID Syndrome (PCS).
- Conditions
- Post COVID-19 Condition
- Being tested
- Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks, Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeksProcedure or surgery
The Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) will be administered through an FDA-approved Transcranial Magnetic Stimulation (TMS) medical device. Results of the baseline EEG will be uploaded to NoetherTech's EMBP software on the Mayo Clinic campus, and transferred to Noethertech servers for TMS parameter determination
TMS treatment will be one 30 min session per day, 5 days per week (Monday-Friday), for 2 weeks.
Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeksProcedure or surgery
The Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) will be administered through an FDA-approved Transcranial Magnetic Stimulation (TMS) medical device. Results of the baseline EEG will be uploaded to NoetherTech's EMBP software on the Mayo Clinic campus, and transferred to Noethertech servers for TMS parameter determination
TMS treatment will be one 30 min session per day, 5 days per week (Monday-Friday), for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Anosmia | Experimental | Subjects Olfactory Threshold Test scores correspond to Anosmia or Hyposmia Receives: Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks |
| Tinnitus | Experimental | Subjects have >0 score on Tinnitus Handicap Inventory (not present prior to COVID infection) Receives: Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks |
| Fatigue | Experimental | Subjects have Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above Receives: Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score
Subjects in the Anosmia group will be assessed using the the University of Pennsylvania Smell Identification Test (UPSIT) test is commercially available booklet of 40 scratch-and-sniff odors, arranged in microencapsulated "scratch and sniff" format. Each correct identification is worth one point, with a score of 40 indicating a perfect smell. It has been used for the assessment of anosmia in COVID-19.
Measured: Baseline, 2 weeks, 10 weeks
Change in Tinnitus Handicap Inventory Scale score
Subjects in the Tinnitus group will be assessed using the Tinnitus Handicap Scale (THI) is a 25-item questionnaire that assesses the severity of tinnitus. The THI is scored using a 5-point Likert Scale. The THI total score ranges from 0 to 100, with a higher score indicating a greater handicap from tinnitus.
Measured: Baseline, 2 weeks, 10 weeks
Change in Modified Fatigue Impact Scale score
Subjects in the Fatigue group will be assessed using the Modified Fatigue Impact Scale (MFIS) is scored using a 5-point Likert scale. The scale ranges from 0 to 4, with 0 = 'Never' to 4 = 'Almost always'. The total obtainable score is 20. Higher scores indicate greater fatigue.
Measured: Baseline, 4 weeks, 12 weeks
Secondary outcomes (5)
Change in General Anxiety Disorder-7 (GAD-7) score
The General Anxiety Disorder 7-item (GAD 7) scale will assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.
Measured: Baseline, 12 weeks
Change in Patient Health Questionnaire-9 score
The Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
Measured: Baseline, 12 weeks
Change in PROMIS Global-10 score
The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: Baseline, 12 weeks
Change in alpha wave characteristics measured via EEG.
Measured: 1 week, 12 weeks
Number of serious adverse events (SAEs)
Number of occurrences of serious adverse events (SAEs) throughout the study duration.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start22 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865222
- Sponsor's protocol ID
- 22-011546
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Pulse Transcranial Magnetic Stimulation for Treatment of Post COVID Syndrome
- ClinicalTrials.gov ID
- NCT06865222
- Acronym / sponsor ID
- 22-011546
- Conditions
- Post COVID-19 Condition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
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 test if Variable Pulse TMS (Transcranial Magnetic Stimulation) can result in objective improvements in patients with Post COVID Syndrome (PCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anosmia | Experimental | Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeksSubjects Olfactory Threshold Test scores correspond to Anosmia or Hyposmia |
| Tinnitus | Experimental | Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeksSubjects have >0 score on Tinnitus Handicap Inventory (not present prior to COVID infection) |
| Fatigue | Experimental | Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeksSubjects have Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have had a recent episode of COVID-19 and who present to the Post COVID-19 Clinic at Mayo Clinic Rochester with at least one of the PCC symptoms of interest - anosmia, tinnitus, fatigue. Symptoms consistent with PCC lasting at least 1 month after the positive test date. Subjects must have ongoing symptoms for > 4 weeks following the start of an acute covid infection. This is consistent with the CDC definition for post covid conditions. Start date is determined by date of first positive COVID test. There is no limitation of maximum time from acute infection start.
- At least one of the PCC symptoms of interest:
Key exclusion criteria (12 listed)
- Implanted electronic devices, including pacemakers, defibrillators, implant medication pumps, or vagus nerve stimulators (VNS)
- Active alcohol abuse: >14 drinks a week or formal diagnosis, illicit drug use or drug abuse
- Any seizure history within the past 10 years
- Intracranial implant within 30 cm of magnet (e.g., aneurysm clips, endovascular coil, cerebral shunts, brain stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
- Enrolled or plans to enroll in an interventional trial during this study
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 |
|---|---|---|
| Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeksThe Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) will be administered through an FDA-approved Transcranial Magnetic Stimulation (TMS) medical device. Results of the baseline EEG will be uploaded to NoetherTech's EMBP software on the Mayo Clinic campus, and transferred to Noethertech servers for TMS parameter determination TMS treatment will be one 30 min session per day, 5 days per week (Monday-Friday), for 2 weeks. | Procedure or surgery | Anosmia, Tinnitus |
| Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeksThe Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) will be administered through an FDA-approved Transcranial Magnetic Stimulation (TMS) medical device. Results of the baseline EEG will be uploaded to NoetherTech's EMBP software on the Mayo Clinic campus, and transferred to Noethertech servers for TMS parameter determination TMS treatment will be one 30 min session per day, 5 days per week (Monday-Friday), for 4 weeks. | Procedure or surgery | Fatigue |
Primary outcome
Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score
Time frame: Baseline, 2 weeks, 10 weeks
Subjects in the Anosmia group will be assessed using the the University of Pennsylvania Smell Identification Test (UPSIT) test is commercially available booklet of 40 scratch-and-sniff odors, arranged in microencapsulated "scratch and sniff" format. Each correct identification is worth one point, with a score of 40 indicating a perfect smell. It has been used for the assessment of anosmia in COVID-19.
Change in Tinnitus Handicap Inventory Scale score
Time frame: Baseline, 2 weeks, 10 weeks
Subjects in the Tinnitus group will be assessed using the Tinnitus Handicap Scale (THI) is a 25-item questionnaire that assesses the severity of tinnitus. The THI is scored using a 5-point Likert Scale. The THI total score ranges from 0 to 100, with a higher score indicating a greater handicap from tinnitus.
Change in Modified Fatigue Impact Scale score
Time frame: Baseline, 4 weeks, 12 weeks
Subjects in the Fatigue group will be assessed using the Modified Fatigue Impact Scale (MFIS) is scored using a 5-point Likert scale. The scale ranges from 0 to 4, with 0 = 'Never' to 4 = 'Almost always'. The total obtainable score is 20. Higher scores indicate greater fatigue.
5 secondary outcomes
Change in General Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline, 12 weeks
Change in Patient Health Questionnaire-9 score
Time frame: Baseline, 12 weeks
Change in PROMIS Global-10 score
Time frame: Baseline, 12 weeks
Change in alpha wave characteristics measured via EEG.
Time frame: 1 week, 12 weeks
Number of serious adverse events (SAEs)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Ryan T. Hurt, M.D. 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 Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks and Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks in people with Post COVID-19 Condition, 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 12 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: looking for participants now, as of the sponsor's last update on 19 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Department of Medicine Research Hub, Coordinator (507-266-1944, domresearchhub@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score (time frame: Baseline, 2 weeks, 10 weeks). The study lists 3 primary outcomes in all. 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 19 Aug 2026.