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

NCT06865222 | Recruiting

• 1 other identifier: 22-011546
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Post COVID-19 Condition

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Change in General Anxiety Disorder-7 (GAD-7) score

  Baseline, 12 weeks

• Change in Patient Health Questionnaire-9 score

  Baseline, 12 weeks

• Change in PROMIS Global-10 score

  Baseline, 12 weeks

• Change in alpha wave characteristics measured via EEG.

  1 week, 12 weeks

• Number of serious adverse events (SAEs)

  2 years

Study Arms (3)

Anosmia

EXPERIMENTAL

Subjects Olfactory Threshold Test scores correspond to Anosmia or Hyposmia

Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks

Tinnitus

EXPERIMENTAL

Subjects have \>0 score on Tinnitus Handicap Inventory (not present prior to COVID infection)

Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 2 weeks

Fatigue

EXPERIMENTAL

Subjects have Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above

Procedure: Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) - 4 weeks

Interventions

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.

Anosmia; Tinnitus

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.

Fatigue

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Interventions

estramustine-binding protein

Study Officials

• Ryan T. Hurt, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Department of Medicine Research Hub, Coordinator

CONTACT

507-266-1944; domresearchhub@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 7, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)