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

Not Applicable

Recruiting

• Conditions: Post COVID-19 Condition

• Registration Number: NCT06865222
• Lead Sponsor: Mayo Clinic

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Study Start: 2025-04
• Primary Completion: 2027-01
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score	Baseline, 2 weeks, 10 weeks	Subjects in the Anosmia group will be assessed using the the University of Pennsylvania Smell Identification Test (UPSIT) test is commercially available booklet of 40 scratch-and-sniff odors, arranged in microencapsulated "scratch and sniff" format. Each correct identification is worth one point, with a score of 40 indicating a perfect smell. It has been used for the assessment of anosmia in COVID-19.
Change in Tinnitus Handicap Inventory Scale score	Baseline, 2 weeks, 10 weeks	Subjects in the Tinnitus group will be assessed using the Tinnitus Handicap Scale (THI) is a 25-item questionnaire that assesses the severity of tinnitus. The THI is scored using a 5-point Likert Scale. The THI total score ranges from 0 to 100, with a higher score indicating a greater handicap from tinnitus.
Change in Modified Fatigue Impact Scale score	Baseline, 4 weeks, 12 weeks	Subjects in the Fatigue group will be assessed using the Modified Fatigue Impact Scale (MFIS) is scored using a 5-point Likert scale. The scale ranges from 0 to 4, with 0 = 'Never' to 4 = 'Almost always'. The total obtainable score is 20. Higher scores indicate greater fatigue.

Secondary Outcome Measures

Name	Time	Method
Change in General Anxiety Disorder-7 (GAD-7) score	Baseline, 12 weeks	The General Anxiety Disorder 7-item (GAD 7) scale will assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.
Change in Patient Health Questionnaire-9 score	Baseline, 12 weeks	The Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
Change in PROMIS Global-10 score	Baseline, 12 weeks	The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Change in alpha wave characteristics measured via EEG.	1 week, 12 weeks
Number of serious adverse events (SAEs)	2 years	Number of occurrences of serious adverse events (SAEs) throughout the study duration.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States