TMS for Stroke

Overseen By Alexander Opitz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Metal implant, Botulinum toxin, Pregnancy, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial magnetic stimulation (TMS), a non-invasive brain treatment using magnetic fields, affects movement abilities in people who have had a stroke. Researchers aim to understand how TMS influences motor cortex excitability, which impacts muscle control, in individuals with or without a past unilateral stroke. Participants are divided into two groups: those who have had a stroke and those who have not, to compare effects. The trial may suit individuals who experienced a stroke over six months ago and continue to face movement difficulties. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance stroke recovery treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had upper extremity botulinum toxin treatment in the last 6 months, you cannot participate.

What prior data suggests that transcranial magnetic stimulation (TMS) is safe for individuals who have suffered a stroke?

Research shows that transcranial magnetic stimulation (TMS) is generally safe and well-tolerated. Studies have found that TMS is safe and painless for most people, though some individuals might experience minor side effects, which are usually not serious.

For stroke patients, TMS has helped improve movement and other abilities. Specifically, the treatment has assisted with issues like limb stiffness and movement problems. While TMS is not new, researchers continue to study its use for stroke recovery to better understand its benefits and any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial magnetic stimulation (TMS) for stroke because it offers a non-invasive way to stimulate brain activity, potentially aiding recovery. Unlike standard treatments like medications and physical therapy, which often focus on managing symptoms and regaining function over time, TMS targets the brain's motor cortex directly. This technique uses magnetic fields to activate nerve cells, which could speed up recovery by enhancing brain plasticity and improving motor function. TMS is particularly promising because it might offer quicker improvements in motor skills, giving stroke patients a faster path to regaining independence.

What evidence suggests that TMS might be an effective treatment for stroke?

Research has shown that transcranial magnetic stimulation (TMS) can improve movement after a stroke. In this trial, participants with unilateral stroke will receive TMS targeting the motor cortex on both the affected and non-affected hemispheres. Studies have found that TMS can significantly enhance arm and hand movement for stroke survivors. It may also help with other stroke-related issues, such as swallowing difficulties and cognitive problems. TMS uses magnetic fields to stimulate brain cells, particularly in areas that control movement. Overall, evidence supports TMS as a promising treatment to help stroke patients regain some lost abilities. ^{1 2 4 6 7}

Who Is on the Research Team?

Alexander Opitz, PhD

Principal Investigator

University of Minnesota Department of Biomedical Engineering

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a stroke over 6 months ago and are facing motor difficulties. Participants must be able to communicate in English. Those with metal or electric implants, recent botulinum toxin treatments in the upper extremities, current pregnancy or breastfeeding, or a history of seizures cannot join.

Inclusion Criteria

I have had a stroke over 6 months ago and still experience movement problems.

Confident level of English language

Exclusion Criteria

I have had a seizure without a known cause.

Pregnancy or breastfeeding

You have a metal or electric implant in your head, neck, or chest.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Assessment

Assessment of stroke characteristics and MRI scan for participants with stroke; confirmation of lack of unilateral stroke for participants without stroke

1 day

1 visit (in-person)

TMS Experiment

Main transcranial magnetic stimulation experiment to measure motor evoked potentials (MEPs) and study phase-dependent cortical excitability

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after TMS treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TMS

Trial Overview

The study is examining how transcranial magnetic stimulation (TMS) affects the excitability of the motor cortex in stroke survivors. It specifically looks at how different phases of brain wave rhythms influence this excitability.

How Is the Trial Designed?

Group I: Participants Without Unilateral Stroke Experimental Treatment 1 Intervention

Participants without self-reported unilateral stroke will take part in two experimental sessions: First, for assessment of stroke characteristics, and second, the main transcranial magnetic stimulation experiment. During the first experimental session, the lack of unilateral stroke will be confirmed. In participants without stroke, TMS will be applied targeting at the intensity of up to 120% resting motor threshold both left and right hemisphere.

Group II: Participants With Unilateral Stroke Experimental Treatment 1 Intervention

Participants with self-reported unilateral stroke will take part in two experimental sessions: First, for assessment of stroke characteristics and MRI scan, and second, the main transcranial magnetic stimulation experiment. During the first experimental session, the unilateral stroke will be confirmed. In participants with stroke, TMS will be applied over the motor cortex on the affected and non-affected hemisphere at the intensity of up to 120% resting motor threshold.

TMS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in European Union as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in Canada as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study involving 60 stroke patients, combining low-frequency repetitive transcranial magnetic stimulation (rTMS) with functional electrical stimulation (FES) significantly improved hand function compared to either treatment alone.

The combination therapy led to better scores in the Fugl-Meyer assessment and total active movement of fingers, indicating enhanced recovery of hand functions such as grasping and pinching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation combined with functional electrical stimulation on hand function of stroke: A randomized controlled trial. Yang, Z., Qiao, L., He, J., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) significantly improves lower limb motor function in stroke patients, with a standardized mean difference of 0.66 for body function and activity, based on a meta-analysis of 8 studies involving 169 participants.

The treatment is considered safe, with only one study reporting mild adverse effects, indicating that rTMS could be a beneficial short-term therapy for enhancing recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of lower limb motor function in patients with stroke: a systematic review and meta-analysis of randomized controlled trials. Tung, YC., Lai, CH., Liao, CD., et al.[2022]

In a pilot study involving 60 patients with ischemic stroke, both 5-Hz stimulation of the lesioned hemisphere and 1-Hz inhibition of the contra-lesional hemisphere using rTMS significantly improved motor function, as measured by various clinical assessments over 12 weeks.

The improvements in motor recovery were sustained without any significant adverse events, supporting the idea that rTMS can effectively aid rehabilitation in stroke patients by restoring balance between the brain's hemispheres.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation at 1Hz and 5Hz produces sustained improvement in motor function and disability after ischaemic stroke. Emara, TH., Moustafa, RR., ElNahas, NM., et al.[2022]

Transcranial magnetic stimulation (TMS) has a very low seizure risk, with only 0.08 seizures reported per 1,000 sessions, and less than 0.02 seizures per 1,000 sessions when guidelines are followed for individuals without known risk factors.

The study found that exceeding safety guidelines increases the risk of seizures, and seizures are more likely to occur during the first few TMS sessions, suggesting that TMS is generally safe when administered properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Lerner, AJ., Wassermann, EM., Tamir, DI.[2021]

Repetitive transcranial magnetic stimulation (rTMS) significantly improved motor function in stroke patients within the first month after treatment, particularly in upper limb function, as shown by various motor functional scores assessed over time.

The benefits of rTMS on upper extremity function were observed to last for up to one year, indicating its potential as a long-term therapeutic intervention for motor recovery after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of repetitive transcranial magnetic stimulation (rTMS) after acute stroke: A one-year longitudinal randomized trial. Guan, YZ., Li, J., Zhang, XW., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

Repetitive transcranial magnetic stimulation (rTMS) shows variable effects on corticospinal pathway excitability in healthy adults, with different frequencies producing different outcomes, indicating that the optimal parameters for rTMS are not yet established.

In stroke patients, there is a trend suggesting that 10 sessions of 3 Hz rTMS may aid in the recovery of motor-evoked potentials, but overall evidence is insufficient to determine effective dosing for improving motor function in paretic limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informing dose-finding studies of repetitive transcranial magnetic stimulation to enhance motor function: a qualitative systematic review. Hiscock, A., Miller, S., Rothwell, J., et al.[2018]

In a study of 41 patients with poststroke cognitive impairment, both 5 Hz rTMS and intermittent theta burst stimulation (iTBS) showed significant improvements in cognitive function compared to sham stimulation, particularly in attention and memory.

The 5 Hz rTMS protocol was especially effective in enhancing attention, suggesting it may play a crucial role in slowing cognitive decline and promoting neuroplasticity after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency versus theta burst transcranial magnetic stimulation for the treatment of poststroke cognitive impairment in humans Tsai, PY., Lin, WS., Tsai, KT., et al.[2021]

In a study involving 20 patients in the subacute phase of stroke, high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) combined with a rehabilitation program (RP) significantly improved upper limb function, particularly in box and block test performance and grip strength compared to the control group.

HF-rTMS appears to be a safe and effective treatment option for enhancing recovery in hemiparesis patients after stroke, suggesting its potential as a practical rehabilitation modality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of High-Frequency Repetitive Transcranial Magnetic Stimulation on Functional Indices of Affected Upper Limb in Patients with Subacute Stroke. Moslemi Haghighi, F., Kordi Yoosefinejad, A., Razeghi, M., et al.[2022]

High-frequency rTMS (20 and 25 Hz) applied to the motor cortex of chronic stroke patients may increase the risk of seizures, as indicated by EMG bursts and muscle excitation observed during the study.

Despite the safety concerns, the study found no significant increase in motor cortex excitability or improvement in hand strength after rTMS, suggesting that the stimulation parameters used may not be effective for rehabilitation in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety study of high-frequency transcranial magnetic stimulation in patients with chronic stroke. Lomarev, MP., Kim, DY., Richardson, SP., et al.[2016]

A review of 84 single pulse and paired-pulse TMS studies with 1091 Parkinson's disease patients, and 77 repetitive TMS studies with 1137 patients, found a very low risk of adverse events, with no seizures reported.

The overall risk of adverse events from rTMS was 0.040 per patient, with common side effects being mild and transient, such as headaches and scalp pain, indicating that TMS is generally safe for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. Vonloh, M., Chen, R., Kluger, B.[2021]

In a study involving 18 subjects with major depression, repetitive transcranial magnetic stimulation (rTMS) for up to 4 weeks was found to be generally safe, with no significant mean deficits in neuropsychologic function or auditory thresholds.

However, two patients experienced mild high-frequency hearing loss, indicating that while rTMS is safe for most, individual responses may vary and warrant further investigation into long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 2- to 4-week course of repetitive transcranial magnetic stimulation (rTMS) on neuropsychologic functioning, electroencephalogram, and auditory threshold in depressed patients. Loo, C., Sachdev, P., Elsayed, H., et al.[2019]

In a study of 63 obese individuals undergoing a 5-week rTMS treatment for weight control, the treatment showed a reassuring safety profile with no unexpected adverse events reported up to one year after treatment.

The most common side effects were moderate headaches (40.4%) and local pain/discomfort (19.2%), particularly more frequent in the high-frequency rTMS group, but overall, rTMS was well tolerated in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repeated sessions of deep transcranial magnetic stimulation in obesity. Ferrulli, A., Massarini, S., Macrì, C., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective therapy for post-stroke rehabilitation, enhancing neuroplasticity and helping patients recover motor skills and cognitive functions.

rTMS can optimize brain activity by applying targeted electromagnetic pulses to specific brain regions, leading to improvements in various stroke-related complications such as motor disorders, aphasia, and depression, although more extensive clinical trials are needed for broader recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evidence on transcranial magnetic stimulation and its potential usefulness in post-stroke neurorehabilitation: Opening new doors to the treatment of cerebrovascular disease. León Ruiz, M., Rodríguez Sarasa, ML., Sanjuán Rodríguez, L., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) showed significant improvements in balance and mobility in stroke patients, based on a review of 15 trials involving 385 participants.

Despite these positive effects, rTMS did not demonstrate significant immediate improvements in lower limb function as measured by the Fugl-Meyer Assessment, indicating that while it may help with mobility and balance, its effectiveness for overall lower limb recovery remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation for the Treatment of Lower Limb Dysfunction in Patients Poststroke: A Systematic Review with Meta-Analysis. Ghayour-Najafabadi, M., Memari, AH., Hosseini, L., et al.[2020]

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ahajournals.org

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sciencedirect.com

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