Transcranial Magnetic Stimulation for Post-COVID Syndrome
Recruiting in Palo Alto (17 mi)
Overseen ByRyan T. Hurt, M.D.
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
No Placebo Group
Trial Summary
What is the purpose of 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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the treatment Electromagnetic Brain Pulsing Variable Pulse Protocol (EMBP) for Post-COVID Syndrome?
A case report showed that a patient with long-COVID symptoms, including breathing difficulties, loss of smell, and cognitive issues, experienced improvements after 10 sessions of EMBP treatment. The patient had better mood, sense of smell, and cognitive function, along with improved breathing capacity.
12345Is transcranial magnetic stimulation safe for humans?
Transcranial magnetic stimulation (TMS) is generally considered safe for humans, with studies showing it is well-tolerated in conditions like mild traumatic brain injury and post-concussion symptoms. Some common side effects include headaches and sleep disturbances, but these are usually mild and temporary.
12678How is the treatment Transcranial Magnetic Stimulation for Post-COVID Syndrome unique?
This treatment is unique because it uses a personalized transcranial magnetic stimulation protocol guided by the patient's brain activity (EEG), which is noninvasive and has shown early success in improving symptoms like brain fog, mood, and sense of smell in long-COVID patients.
125910Eligibility Criteria
This trial is for individuals experiencing lingering symptoms after recovering from COVID-19, known as Post-COVID Syndrome. Specific eligibility criteria are not provided.Inclusion Criteria
I have lost my sense of smell, experience ringing in my ears, or feel very tired since having COVID-19.
I had COVID-19 and have been experiencing loss of smell, ringing in the ears, or fatigue for over a month.
Exclusion Criteria
I am able to understand and sign the informed consent.
I had a stroke and still have lasting effects.
I have not had a seizure in the last 10 years.
I cannot understand or follow spoken instructions.
Participant Groups
The study is testing a treatment called Variable Pulse Transcranial Magnetic Stimulation (TMS) over two different durations: one group for 2 weeks and another for 4 weeks, to see if it can improve PCS symptoms.
3Treatment groups
Experimental Treatment
Group I: TinnitusExperimental Treatment1 Intervention
Subjects have \>0 score on Tinnitus Handicap Inventory (not present prior to COVID infection)
Group II: FatigueExperimental Treatment1 Intervention
Subjects have Total Modified Fatigue Impact Scale (MFIS) Score of 40 or above
Group III: AnosmiaExperimental Treatment1 Intervention
Subjects Olfactory Threshold Test scores correspond to Anosmia or Hyposmia
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
Case Report of Improvement in Long-COVID Symptoms in an Air Force Medic Treated With Transcranial Magnetic Stimulation Using Electro-Magnetic Brain Pulse Technique. [2023]Long-coronavirus disease (COVID) is an ill-defined set of symptoms persisting in patients following infection with COVID-19 that range from any combination of persistent breathing difficulties to anosmia, impaired attention, memory, fatigue, or pain. Recently, noninvasive transcutaneous electrical brain stimulation techniques have been showing early signs of success in addressing some of these complaints. We postulate that the use of a stimulation technique with transcranial magnetic stimulation may also similarly be effective. A 36-year-old male suffering from symptoms of dyspnea, anosmia, and "brain fog" for 2 years following coronavirus infection was treated with 10 sessions of Electro-Magnetic Brain Pulse (EMBP®), a personalized transcranial magnetic stimulation protocol guided by the patient's electroencephalograph (EEG). At the conclusion of the treatment, the patient had improvements in mood, sense of smell, and brain fogging. Dyspnea also decreased with a gain of 11% forced expiratory volume 1/forced vital capacity. A high-sensitivity athletic training cognitive test showed an overall 27% increase in aggregate score. A significant portion of this was attributed to changes in visual clarity and decision-making speed. Post-treatment EEG showed a shift from predominantly delta waves to more synchronized alpha wave patterns during the resting state. Brain stimulation techniques appear to be showing early signs of success with long-COVID symptoms. This is the first case describing the use of a magnetic stimulation technique with quantitative test results and recorded EEG changes. Given the early success in this patient with cognition, dyspnea, and anosmia, this noninvasive treatment modality warrants further research.
Left Dorsolateral Prefrontal Cortex rTMS in Alleviating MTBI Related Headaches and Depressive Symptoms. [2022]Persistent mild traumatic brain injury related headache (MTBI-HA) represents a neuropathic pain state. This study tested the hypothesis that repetitive transcranial magnetic stimulation (rTMS) at the left prefrontal cortex can alleviate MTBI-HA and associated neuropsychological dysfunctions.
Noninvasive Transcranial Magnetic Brain Stimulation in Stroke. [2019]It is likely that transcranial magnetic brain stimulation will be used for the clinical treatment of stroke and stroke-related impairments in the future. The anatomic target and stimulation parameters will likely vary for any clinical focus, be it weakness, pain, or cognitive or communicative dysfunction. Biomarkers may also be useful for identifying patients who will respond best, with a goal to enhance clinical decision making. Combination with drugs or specific types of therapeutic exercise may be necessary to achieve maximal response.
fMRI findings in MTBI patients with headaches following rTMS. [2022]Mild Traumatic Brain Injury (MTBI) patients with persistent headaches are known to have diminished supraspinal modulatory connectivity from their prefrontal cortices. Repetitive transcranial magnetic stimulation (rTMS) is able to alleviate MTBI-related headache (MTBI-HA). This functional magnetic resonance imaging (fMRI) study assessed supraspinal correlates associated with the headache analgesic effect of rTMS at left prefrontal cortex (LPFC), hypothesizing real rTMS would significantly increase modulatory functions at LPFC in comparison to sham treatment. Subjects with MTBI-HA were randomized to receive either real or sham rTMS treatments and subjected to pre- and post-treatment resting state and evoked heat-pain fMRI as described in a prior study. Real rTMS consisted of 2000 pulses delivered at 10 Hz and 80% of the resting motor threshold at left dorsolateral prefrontal cortex, whereas sham treatment was delivered with same figure-of-eight coil turned 180 degrees. Follow-up fMRI was performed one-week post-treatment. All fMRI data was processed using BrainVoyager QX Software. 14 subjects receiving real and 12 subjects receiving sham treatments completed the study. The REAL group demonstrated significant (P
Safety and behavioral effects of high-frequency repetitive transcranial magnetic stimulation in stroke. [2018]Electromagnetic brain stimulation might have value to reduce motor deficits after stroke. Safety and behavioral effects of higher frequencies of repetitive transcranial magnetic stimulation (rTMS) require detailed assessment.
Noninvasive brain stimulation for persistent postconcussion symptoms in mild traumatic brain injury. [2022]Mild traumatic brain injury (mTBI) is typically followed by various postconcussive symptoms (PCS), including headache, depression, and cognitive deficits. In 15-25% of cases, PCS persists beyond the usual 3-month recovery period, interfering with activities of daily living and responding poorly to pharmacotherapy. We tested the safety, tolerability, and efficacy of repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) for alleviating PCS. Fifteen eligible patients with mTBI and PCS > 3 months postinjury consented to 20 sessions of rTMS (20 × 5-sec trains; 10 Hz at 110% threshold), with clinical and functional magnetic resonance imaging (fMRI) assessments before and after intervention and clinical assessment at 3-month follow-up. Primary outcomes were tolerability, safety, and efficacy, as measured with the PCS Scale. Secondary outcomes included the Cognitive Symptoms Questionnaire, neuropsychological test performance, and working memory task-associated activity as assessed with fMRI. Twelve patients completed all sessions. Three withdrew because of worsening symptoms or for an unrelated event. Stimulation intensity was increased gradually across sessions, and all subjects tolerated the protocol by the sixth session. Commonly reported side effects among completers were increased headache (n = 3) and greater sleep disturbance (n = 3). Participants also reported positive outcomes such as less sleep disturbance (n = 3), and better mental focus (n = 3). On average, PCS scores declined by 14.6 points (p = 0.009) and fMRI task-related activation peaks in the DLPFC increased after rTMS. rTMS is safe, tolerated by most patients with mTBI, and associated with both a reduction in severity of PCS and an increase in task-related activations in DLPFC. Assessment of this intervention in a randomized, control trial is warranted.
Safety Considerations for the Use of Transcranial Magnetic Stimulation as Treatment for Coma Recovery in People With Severe Traumatic Brain Injury. [2022]For persons in states of disordered consciousness (DoC) after severe traumatic brain injury (sTBI), we report cumulative findings from safety examinations, including serious adverse events (AEs) of a repetitive transcranial magnetic stimulation (rTMS) parameter protocol in 2 different studies.
Repetitive Transcranial Magnetic Stimulation in Managing Mild Traumatic Brain Injury-Related Headaches. [2022]Headache is one of the most common debilitating chronic pain conditions in either active or retired military personnel with mild traumatic brain injury (MTBI). This study assessed the effect of repetitive transcranial magnetic stimulation (rTMS) in alleviating MTBI-related headache (MTBI-HA).
Effects of transcranial magnetic stimulation in modulating cortical excitability in patients with stroke: a systematic review and meta-analysis. [2022]Transcranial magnetic stimulation (TMS) has attracted plenty of attention as it has been proved to be effective in facilitating motor recovery in patients with stroke. The aim of this study was to systematically review the effects of repetitive TMS (rTMS) and theta burst stimulation (TBS) protocols in modulating cortical excitability after stroke.
Transcranial magnetic stimulation in clinical practice. [2018]Transcranial magnetic stimulation allows a non-invasive and painless stimulation of the human brain and cranial nerves. The method is in use since 1985. Transcranial magnetic stimulation can use single stimuli, pairs of stimuli separated by different intervals (to the same or to several brain areas), or trains of repetitive stimuli at various frequencies. Single stimuli give rise to motor evoked potentials that have clinical use and serve diagnostic and prognostic purposes. Repetitive transcranial magnetic stimulation can modify excitability of cerebral cortex. Repetitive transcranial magnetic stimulation has opened a new field of investigation of the neural circuitry, and is developing into a therapeutic tool. This general review considers basic principles of transcranial magnetic stimulation, discusses methodological aspects and techniques, and analyses their utility in clinical practice.