Clinical trial NCT06865222: Post COVID-19 Syndrome Treatment With Variable Pulse Transcranial Magnetic Stimulation
Official title: Variable Pulse Transcranial Magnetic Stimulation for Treatment of Post COVID Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post COVID-19 Condition
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score
timeFrame: Baseline, 2 weeks, 10 weeks
measure: Change in Tinnitus Handicap Inventory Scale score
timeFrame: Baseline, 2 weeks, 10 weeks
measure: Change in Modified Fatigue Impact Scale score
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change in General Anxiety Disorder-7 (GAD-7) score
timeFrame: Baseline, 12 weeks
measure: Change in Patient Health Questionnaire-9 score
timeFrame: Baseline, 12 weeks
measure: Change in PROMIS Global-10 score
timeFrame: Baseline, 12 weeks
measure: Change in alpha wave characteristics measured via EEG.
timeFrame: 1 week, 12 weeks
measure: Number of serious adverse events (SAEs)
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan T. Hurt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: