Post COVID-19 Syndrome Treatment With Variable Pulse Transcranial Magnetic Stimulation
ConditionPost COVID-19 Condition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMayo Clinic
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks
Procedure/SurgeryThe 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.
Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks
Procedure/SurgeryThe 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.
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: AnosmiaExperimental treatment 1 intervention
Group B: TinnitusExperimental treatment 1 intervention
Group C: FatigueExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 2 weeks, 10 weeks2
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.
Time frame
Baseline, 2 weeks, 10 weeks3
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.
Time frame
Baseline, 4 weeks, 12 weeksSecondary outcomes
1
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.
Time frame
Baseline, 12 weeks2
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.
Time frame
Baseline, 12 weeks3
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.
Time frame
Baseline, 12 weeks4
Change in alpha wave characteristics measured via EEG.
Time frame
1 week, 12 weeksSponsors and contacts
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Source ClinicalTrials.gov