Actively Recruiting
Variable Pulse Transcranial Magnetic Stimulation for Treatment of Post COVID Syndrome
Led by Mayo Clinic · Updated on 2025-08-14
40
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Variable Pulse Transcranial Magnetic Stimulation (TMS) to see if it can improve symptoms in patients with Post COVID Syndrome (PCS), including anosmia, tinnitus, and fatigue. This study is sponsored by Mayo Clinic and focuses on adults aged 18 to 65 who have ongoing symptoms lasting more than 4 weeks after a confirmed COVID-19 infection. The study aims to measure changes in smell, tinnitus, and fatigue scores as primary outcomes to assess treatment effects. The treatment involves an Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) delivered using an FDA-approved TMS device. Participants will receive one 30-minute TMS session per day, five days a week (Monday through Friday), for either 2 weeks or 4 weeks, depending on the assigned group. Baseline EEG results will guide personalized TMS parameters for each participant. The study has three groups based on specific symptoms: anosmia, tinnitus, and fatigue. Participants will undergo evaluations including smell identification tests, tinnitus impact scales, fatigue scales, anxiety and depression questionnaires, and EEG measurements at various points during and after treatment. Safety will be monitored for up to two years, tracking serious adverse events. The study duration includes multiple assessments at baseline, 1 to 12 weeks after treatment, and extended follow-up to understand long-term effects.
CONDITIONS
Brief Title
Post COVID-19 Syndrome Treatment With Variable Pulse Transcranial Magnetic Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a recent COVID-19 infection attending the Post COVID-19 Clinic with at least one symptom: anosmia, tinnitus, or fatigue
- Symptoms consistent with Post COVID Condition lasting more than 1 month after the positive COVID test
- Ongoing symptoms for more than 4 weeks following acute COVID infection
- Anosmia confirmed by Olfactory Threshold Test scores indicating anosmia or hyposmia
- Tinnitus with a score above 0 on the Tinnitus Handicap Inventory, not present before COVID infection
- Fatigue with a Modified Fatigue Impact Scale score of 40 or higher
You will not qualify if you...
- Having implanted electronic devices such as pacemakers, defibrillators, implant medication pumps, or vagus nerve stimulators
- Active alcohol abuse (more than 14 drinks per week or formal diagnosis), illicit drug use, or drug abuse
- History of seizures within the past 10 years
- Intracranial implants or metal objects near the head that cannot be safely removed
- Currently enrolled or planning to enroll in another interventional trial
- Previous stroke with residual deficits
- Unable to understand or follow verbal commands
- Unable to comprehend and sign informed consent
- Medical conditions preventing tolerance of trial procedures as assessed by physicians
- Clinically unstable or abnormal medical conditions posing safety risks
- Pregnant or trying to become pregnant; negative pregnancy test required for females of childbearing potential
- Any condition that may prevent study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 4 weeks
Participants receive daily 30-minute Transcranial Magnetic Stimulation sessions, 5 days a week (Monday to Friday), for either 2 or 4 weeks depending on their assigned group.
Daily visits, 5 days per week
Duration - Up to 12 weeks after treatment
Participants are monitored to assess changes in symptoms and safety after completing the treatment.
Visits at 10 to 12 weeks post-baseline
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
D
Department of Medicine Research Hub, Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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