Treatment for Post COVID-19 Syndrome using Transcranial Magnetic Stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Variable Pulse Transcranial Magnetic Stimulation (TMS) in improving symptoms associated with Post COVID-19 Syndrome (PCS). Participants will undergo two different treatment protocols over a period of 2 to 4 weeks. The study focuses on patients experiencing symptoms such as anosmia, tinnitus, and fatigue that have persisted for at least one month following a COVID-19 infection. The goal is to determine if TMS can lead to measurable improvements in these symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ryan T. Hurt, M.D. — Mayo Clinic
• Study coordinator: Department of Medicine Research Hub, Coordinator
• Email: domresearchhub@mayo.edu
• Phone: 507-266-1944

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.