The purpose of this study is to test if Variable Pulse TMS (Transcranial MagneticStimulation) can result in objective improvements in patients with Post COVID Syndrome(PCS).
Not Provided
Procedure: 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.
Procedure: 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.
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
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Investigator: Ryan T. Hurt
Department of Medicine Research Hub, Coordinator
507-266-1944
domresearchhub@mayo.edu
Ryan T. Hurt, M.D., Principal Investigator
Mayo Clinic