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

Официальное название

Variable Pulse Transcranial Magnetic Stimulation for Treatment of Post COVID Syndrome

Обзор

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).

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score [Срок оценки: Baseline, 2 weeks, 10 weeks]
• Change in Tinnitus Handicap Inventory Scale score [Срок оценки: Baseline, 2 weeks, 10 weeks]
• Change in Modified Fatigue Impact Scale score [Срок оценки: Baseline, 4 weeks, 12 weeks]

Вторичные конечные точки (5)

• Change in General Anxiety Disorder-7 (GAD-7) score [Срок оценки: Baseline, 12 weeks]
• Change in Patient Health Questionnaire-9 score [Срок оценки: Baseline, 12 weeks]
• Change in PROMIS Global-10 score [Срок оценки: Baseline, 12 weeks]
• Change in alpha wave characteristics measured via EEG. [Срок оценки: 1 week, 12 weeks]
• Number of serious adverse events (SAEs) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Идентификаторы

NCT: NCT06865222 · 22-011546

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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