Phase
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
Ages 18-65 All Genders
Study Summary
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
Connect with a study center
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
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