Recruiting

Variable Pulse TMS

Sponsor:

Mayo Clinic

Code:

NCT06865222

Conditions

Post COVID-19 Condition

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks

Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks

Study Details

Brief 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).

Conditions

Post COVID-19 Condition

Study ID

NCT06865222

Start date

Jul 22, 2025

Status verified date

Aug, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Anosmia

Subjects Olfactory Threshold Test scores correspond to Anosmia or Hyposmia

experimental: Tinnitus

Subjects have >0 score on Tinnitus Handicap Inventory (not present prior to COVID infection)

experimental: Fatigue

Subjects have Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above

Interventions

Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks

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 weeks

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.

Primary outcome measure

  • Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score [ Time Frame: Baseline, 2 weeks, 10 weeks ]
  • Change in Tinnitus Handicap Inventory Scale score [ Time Frame: Baseline, 2 weeks, 10 weeks ]
  • Change in Modified Fatigue Impact Scale score [ Time Frame: Baseline, 4 weeks, 12 weeks ]

Central Contacts and Locations

Central contacts

Department of Medicine Research Hub, Coordinator

507-266-1944domresearchhub@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Ryan T. Hurt

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-19.