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Recruiting NCT06865222

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

No phase Interventional Post COVID-19 Condition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks, Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks.
Who it may be relevant to
Registry conditions: Post COVID-19 Condition. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Variable Pulse Transcranial Magnetic Stimulation for Treatment of Post COVID Syndrome

Overview

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).

Interventions

  • Procedure Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks
    The Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) will be administered through an FDA-approved Transcranial Magnetic Stimulation (TMS) medical device. Results of the baseline EEG will be uploaded to NoetherTech's EMBP software on the Mayo Clinic campus, and transferred to Noethertech servers for TMS parameter determination TMS treatment will be one 30 min session per day, 5 days per week (Monday-Friday), for 2 weeks.
  • Procedure Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks
    The Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) will be administered through an FDA-approved Transcranial Magnetic Stimulation (TMS) medical device. Results of the baseline EEG will be uploaded to NoetherTech's EMBP software on the Mayo Clinic campus, and transferred to Noethertech servers for TMS parameter determination TMS treatment will be one 30 min session per day, 5 days per week (Monday-Friday), for 4 weeks.

Primary outcome measures

  • Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score [Time frame: Baseline, 2 weeks, 10 weeks]
  • Change in Tinnitus Handicap Inventory Scale score [Time frame: Baseline, 2 weeks, 10 weeks]
  • Change in Modified Fatigue Impact Scale score [Time frame: Baseline, 4 weeks, 12 weeks]
Secondary outcome measures (5)
  • Change in General Anxiety Disorder-7 (GAD-7) score [Time frame: Baseline, 12 weeks]
  • Change in Patient Health Questionnaire-9 score [Time frame: Baseline, 12 weeks]
  • Change in PROMIS Global-10 score [Time frame: Baseline, 12 weeks]
  • Change in alpha wave characteristics measured via EEG. [Time frame: 1 week, 12 weeks]
  • Number of serious adverse events (SAEs) [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06865222 · 22-011546

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗