Treatment for Post COVID-19 Syndrome using Transcranial Magnetic Stimulation
Variable Pulse Transcranial Magnetic Stimulation for Treatment of Post COVID Syndrome
This study is testing if a new brain treatment can help people who are still feeling sick from COVID-19, like having no sense of smell, ringing in the ears, or extreme tiredness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06865222 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals who have recently recovered from COVID-19 and are experiencing persistent symptoms like anosmia, tinnitus, or fatigue.
Not a fit: Patients with implanted electronic devices or those who do not meet the symptom criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from lingering symptoms of COVID-19.
How similar studies have performed: While the use of TMS for various conditions has shown promise, this specific application for Post COVID-19 Syndrome is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.