Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anosmia | Experimental | Subjects Olfactory Threshold Test scores correspond to Anosmia or Hyposmia |
|
| Tinnitus | Experimental | Subjects have >0 score on Tinnitus Handicap Inventory (not present prior to COVID infection) |
|
| Fatigue | Experimental | Subjects have Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in University of Pennsylvania Smell Identification Test (UPSIT) Olfactory Threshold Test score | 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. | Baseline, 2 weeks, 10 weeks |
| Change in Tinnitus Handicap Inventory Scale score | 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. | Baseline, 2 weeks, 10 weeks |
| Change in Modified Fatigue Impact Scale score | 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. | Baseline, 4 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in General Anxiety Disorder-7 (GAD-7) score | 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. |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Department of Medicine Research Hub, Coordinator | Contact | 507-266-1944 | domresearchhub@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ryan T. Hurt, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks | Procedure | 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. |
|
| Baseline, 12 weeks |
| Change in Patient Health Questionnaire-9 score | 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. | Baseline, 12 weeks |
| Change in PROMIS Global-10 score | 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. | Baseline, 12 weeks |
| Change in alpha wave characteristics measured via EEG. | 1 week, 12 weeks |
| Number of serious adverse events (SAEs) | Number of occurrences of serious adverse events (SAEs) throughout the study duration. | 2 years |
| ID | Term |
|---|---|
| C028321 | estramustine-binding protein |
Not provided
Not provided
Not provided