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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Anosmia 		Subjects Olfactory Threshold Test scores correspond to Anosmia or Hyposmia
  • 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.
Experimental
Tinnitus 		Subjects have >0 score on Tinnitus Handicap Inventory (not present prior to COVID infection)
  • 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.
Experimental
Fatigue 		Subjects have Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above
  • 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.

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Ryan T. Hurt

More Details

NCT ID
NCT06865222
Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Department of Medicine Research Hub, Coordinator
507-266-1944
domresearchhub@mayo.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.