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

ConditionPost COVID-19 Condition

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMayo Clinic

About this trial

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

Qualifiers

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.

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks
Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks

Treatment groups

40 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov