TMS for Aphasia

Overseen By Sidney Schoenrock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must not be taking: Pro-convulsants

Disqualifiers: Severe cognitive impairments, Untreated psychiatric disease, Unstable medical condition, Pregnancy, Alcoholism, 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: 1

Duration: 1 day

135 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how Transcranial Magnetic Stimulation (TMS), a treatment using magnetic fields, can enhance language skills in individuals who have experienced a stroke and now have aphasia (difficulty speaking or understanding language). The trial will compare different TMS methods, including active and sham (placebo) treatments. Individuals who have had a stroke on the left side of their brain, are right-handed, and fluent in English might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in stroke recovery and language improvement.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes people on pro-convulsant medications. It's best to discuss your specific medications with the trial team.

What prior data suggests that Transcranial Magnetic Stimulation is safe for people with stroke and aphasia?

In a previous study, researchers found that transcranial magnetic stimulation (TMS) can safely help people with aphasia, a speech disorder that occurs after a stroke. Other studies have shown that TMS is generally well-tolerated, with most people experiencing no serious side effects. Common side effects include mild headaches or scalp discomfort, which usually resolve quickly. Overall, TMS has proven to be a safe option for improving speech in stroke patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) for aphasia is unique because it uses magnetic fields to stimulate nerve cells in the brain, which is a different approach compared to traditional speech therapy and medications that are often used to treat this condition. Researchers are excited about TMS because it offers a non-invasive method to potentially improve language function by directly targeting brain areas responsible for speech. Unlike other treatments that may have slower or less direct effects, TMS could provide more immediate and targeted benefits, which is why it holds promise for those with aphasia.

What evidence suggests that Transcranial Magnetic Stimulation might be an effective treatment for aphasia?

Research has shown that Transcranial Magnetic Stimulation (TMS) can help treat language problems in stroke patients. Studies have found that TMS improves skills like naming objects, repeating words, writing, and understanding language. This trial will compare different TMS approaches: participants may receive Active TMS, Control TMS, or Sham TMS. One study found that TMS had strong and lasting effects on language recovery, with clear improvements in language abilities. Another study suggested that combining TMS with language therapy can enhance these positive results. Overall, TMS shows promise in helping people with language difficulties after a stroke regain their communication skills. ^{2 4 6 7 8}

Who Is on the Research Team?

Priyanka Shah-Basak, PhD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for right-handed, English-speaking adults over 18 who've had a left hemisphere stroke at least one month ago and are experiencing language difficulties. It's not suitable for those with implants near the scalp, metal in their body, seizure risks, heart devices, untreated major psychiatric conditions or cognitive impairments.

Inclusion Criteria

I had a stroke affecting the left side of my brain.

Consent date >= 1 month after stroke onset

Right-handed

Exclusion Criteria

Presence of any other implants near the scalp (e.g., cochlear implants) or in the eye

I have conditions that could make seizures more likely.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repetitive or rapid TMS protocols to evaluate effects on language processes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after TMS administration

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview

The study investigates the impact of Transcranial Magnetic Stimulation (TMS) on language processing in individuals who have suffered from a stroke leading to aphasia as well as in healthy participants.

How Is the Trial Designed?

Group I: Active TMS Experimental Treatment 1 Intervention

Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans (also known as an air-cooled coil) will be used for delivering active repetitive or rapid TMS to the target site.

Group II: Control TMS Active Control 1 Intervention

Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans will be used for delivering active repetitive or rapid TMS to the control site.

Group III: Sham TMS Placebo Group 1 Intervention

Deymed DuoMag XT-100 rTMS system (DM-XT100) connected to a 70-mm figure-of-eight coil with built-in cooling fans will be used for delivering sham repetitive or rapid TMS to the control or target site.

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has shown a significant positive effect on naming accuracy in stroke patients with aphasia, with a strong effect size (SMD = 1.26) based on a meta-analysis of 11 studies involving 242 patients.

The treatment was found to be safe, with no reported adverse effects, and it may enhance overall language function in patients with aphasia, suggesting its potential as a beneficial therapy alongside traditional speech and language therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of rTMS in patients with poststroke aphasia: a systematic review and focused meta-analysis. Gholami, M., Pourbaghi, N., Taghvatalab, S.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has been shown to be more effective than sham rTMS and conventional rehabilitation for improving language recovery in stroke patients with aphasia, based on a meta-analysis of 28 studies involving 1287 patients.

Low-frequency rTMS specifically demonstrated greater improvements in language recovery, particularly in naming and comprehension, while high-frequency rTMS did not show significant benefits compared to sham or conventional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation (rTMS) on aphasia in stroke patients: A systematic review and meta-analysis. Zhang, J., Zhong, D., Xiao, X., et al.[2022]

In a study involving 24 post-stroke patients with aphasia, combining low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) with intensive speech therapy (ST) led to significant improvements in language abilities, particularly for nonfluent aphasic patients who showed enhanced auditory comprehension, reading comprehension, and repetition.

The targeted application of LF-rTMS based on fMRI findings suggests a tailored approach to treatment, with nonfluent patients benefiting from stimulation of the inferior frontal gyrus and fluent patients from stimulation of the superior temporal gyrus, indicating the potential of this method as a neurorehabilitative protocol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of low-frequency rTMS and intensive speech therapy in poststroke patients with aphasia: a pilot study based on evaluation by fMRI in relation to type of aphasia. Abo, M., Kakuda, W., Watanabe, M., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) applied at 1 Hz to the undamaged right hemisphere has shown long-term improvements in naming abilities for chronic stroke patients with nonfluent aphasia, suggesting a potential therapeutic approach for language recovery.

A case study indicated that combining rTMS with speech therapy (constraint-induced language therapy) may enhance the effectiveness of treatment, highlighting the importance of integrated rehabilitation strategies for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation and aphasia rehabilitation. Naeser, MA., Martin, PI., Ho, M., et al.[2021]

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method that can either inhibit or excite brain areas, making it a potential adjuvant treatment for aphasia, a language disorder often resulting from stroke.

In a case study of a 79-year-old man who received rTMS alongside articulation therapy, no significant improvements in language skills were observed, but family reports indicated positive changes in communication patterns, suggesting that further research is needed to fully understand rTMS's effectiveness in treating aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. A reasonable adjuvant therapeutic method in the treatment of post-stroke aphasia?]. Miller, S., Kühn, D., Ptok, M.[2021]

The study involving 20 stroke survivors demonstrated that combining repetitive transcranial magnetic stimulation (rTMS) with multi-modality aphasia therapy (M-MAT) is safe and feasible, with no adverse events reported.

While both treatment groups showed significant improvements in speech and language outcomes, there was no significant difference in effectiveness between the rTMS and sham groups, suggesting that personalized approaches may be needed based on individual lesion locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation (rTMS) combined with multi-modality aphasia therapy for chronic post-stroke non-fluent aphasia: A pilot randomized sham-controlled trial. Low, TA., Lindland, K., Kirton, A., et al.[2023]

Repetitive transcranial magnetic stimulation (rTMS) has shown positive effects on post-stroke aphasia rehabilitation in 12 studies, indicating it can enhance recovery when used alongside conventional therapies or even alone.

No adverse effects were reported in the studies reviewed, suggesting that rTMS is a safe intervention; however, further large-scale, well-designed trials are needed to confirm its efficacy and establish it as a standard treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review on the effectiveness of repetitive transcranial magnetic stimulation (rTMS) on post-stroke aphasia. Wong, IS., Tsang, HW.[2019]

Low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) combined with speech and language therapy (SLT) significantly improves language abilities in patients with poststroke aphasia, as shown in a meta-analysis of 18 studies involving 536 participants.

The treatment is safe, with no reported adverse events, and the most effective LF-rTMS protocol was found to be 20 minutes per session at 90% of the resting motor threshold, administered 5 days a week for 2 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Frequency Repetitive Transcranial Magnetic Stimulation in Patients With Poststroke Aphasia: Systematic Review and Meta-Analysis of Its Effect Upon Communication. Yao, L., Zhao, H., Shen, C., et al.[2021]

Intermittent theta burst stimulation (iTBS) significantly improved language functions in patients with chronic non-fluent aphasia after stroke, outperforming sham treatment and showing better results in conversation and comprehension scores.

Compared to high-frequency 1-Hz rTMS, iTBS was more effective in enhancing overall language recovery, particularly in auditory comprehension, indicating its potential as a superior treatment option for poststroke aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-Frequency vs. Theta Burst Transcranial Magnetic Stimulation for the Treatment of Chronic Non-fluent Aphasia in Stroke: A Proof-of-Concept Study. Chou, TY., Wang, JC., Lin, MY., et al.[2022]

Low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with speech therapy significantly improves language function in patients with nonfluent aphasia after stroke, as shown by higher scores on the Western Aphasia Battery (WAB) scale in the rTMS groups compared to the control group.

Administering rTMS twice a day (2rTMS) further enhances language recovery and increases levels of brain-derived neurotrophic factor (BDNF), which is associated with nerve repair and brain tissue protection, indicating a potential mechanism for the observed improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low-Frequency rTMS and Intensive Speech Therapy Treatment on Patients With Nonfluent Aphasia After Stroke. Bai, G., Jiang, L., Ma, W., et al.[2021]

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