Post COVID-19 Syndrome Treatment With Variable Pulse Transcranial Magnetic Stimulation

Mayo Clinic

Status: Enrolling

Conditions: Post COVID-19 Condition

Treatments: Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks; Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT06865222

22-011546

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Anosmia

Experimental group

Description:

Subjects Olfactory Threshold Test scores correspond to Anosmia or Hyposmia

Treatment:

Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks

Tinnitus

Experimental group

Description:

Subjects have \>0 score on Tinnitus Handicap Inventory (not present prior to COVID infection)

Treatment:

Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks

Fatigue

Experimental group

Description:

Subjects have Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above

Treatment:

Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks