Post COVID-19 Syndrome Treatment with Variable Pulse Transcranial Magnetic Stimulation

Last updated: March 6, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

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

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

Clinical Study ID

NCT06865222
22-011546
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have had a recent episode of COVID-19 and who present to the PostCOVID-19 Clinic at Mayo Clinic Rochester with at least one of the PCC symptoms ofinterest - anosmia, tinnitus, fatigue. Symptoms consistent with PCC lasting at least 1 month after the positive test date. Subjects must have ongoing symptoms for > 4weeks following the start of an acute covid infection. This is consistent with theCDC definition for post covid conditions. Start date is determined by date of firstpositive COVID test. There is no limitation of maximum time from acute infectionstart.

  • 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 toSARS-COVID 2 infection)

  • Fatigue: Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above

Exclusion

Exclusion Criteria:

  • Implanted electronic devices, including pacemakers, defibrillators, implantmedication pumps, or vagus nerve stimulators (VNS)

  • Active alcohol abuse: >14 drinks a week or formal diagnosis, illicit drug use ordrug abuse

  • Any seizure history within the past 10 years

  • Intracranial implant within 30 cm of magnet (e.g., aneurysm clips, endovascularcoil, cerebral shunts, brain stimulators, cochlear implants, stents, or electrodes)or any other metal object within or near the head, excluding the mouth, which cannotbe 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 thetrial procedure due to medical condition

  • Clinical abnormality or clinically unstable medical condition, as indicated bymedical history, physical examination, or clinical laboratory testing, that in theInvestigator's judgment might pose a potential safety risk to the subject or limitinterpretation of the trial results

  • Pregnant or trying to become pregnant; negative urine pregnancy test at screeningwill be required for females of childbearing potential

  • Any condition which in the judgment of the investigator would prevent the subjectfrom completion of the study

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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