TMS for Aphasia

Recruiting in Palo Alto (17 mi)

Overseen by Priyanka Shah-Basak, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will examine the effect of TMS on people with stroke and aphasia as well as healthy individuals.

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 data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for aphasia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve language abilities, like naming, in stroke patients with aphasia (difficulty speaking or understanding language). Studies have found that combining rTMS with speech therapy can lead to long-term improvements in language skills.

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Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Studies show that repetitive transcranial magnetic stimulation (rTMS) is generally safe for humans, with no adverse events reported in trials involving stroke patients with aphasia.

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How is the treatment rTMS unique for aphasia?

Repetitive transcranial magnetic stimulation (rTMS) is unique because it is a non-invasive, painless treatment that uses magnetic fields to stimulate specific areas of the brain, potentially improving language abilities in people with aphasia after a stroke. Unlike traditional speech therapy, rTMS can target brain areas directly to either inhibit or excite them, which may help in enhancing language recovery.

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Eligibility Criteria

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

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical College of Wisconsin Milwaukee, WI

Who Is Running the Clinical Trial?

Medical College of Wisconsin Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation and aphasia rehabilitation. [2021] Repetitive transcranial magnetic stimulation (rTMS) has been reported to improve naming in chronic stroke patients with nonfluent aphasia since 2005. In part 1, we review the rationale for applying slow, 1-Hz, rTMS to the undamaged right hemisphere in chronic nonfluent aphasia patients after a left hemisphere stroke; and we present a transcranial magnetic stimulation (TMS) protocol used with these patients that is associated with long-term, improved naming post-TMS. In part 2, we present results from a case study with chronic nonfluent aphasia where TMS treatments were followed immediately by speech therapy (constraint-induced language therapy). In part 3, some possible mechanisms associated with improvement after a series of TMS treatments in stroke patients with aphasia are discussed.

2. Switzerland 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. [2022] To assess the safety and clinical efficacy of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) combined with intensive speech therapy (ST) in poststroke patients with aphasia.

3. England pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation (rTMS) on aphasia in stroke patients: A systematic review and meta-analysis. [2022] To evaluate the effects and safety of repetitive transcranial magnetic stimulation (rTMS) on aphasia in stroke patients.

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Low-Frequency rTMS and Intensive Speech Therapy Treatment on Patients With Nonfluent Aphasia After Stroke. [2021] To observe the effect of low-frequency repetitive transcranial magnetic stimulation (rTMS) on patients with nonfluent aphasia after stroke.

5. Germany pubmed.ncbi.nlm.nih.gov

A review on the effectiveness of repetitive transcranial magnetic stimulation (rTMS) on post-stroke aphasia. [2019] This evidence-based review reports an updated evaluation and critical appraisal of available studies that investigated the effectiveness of repetitive transcranial magnetic stimulation (rTMS) on post-stroke aphasia rehabilitation.

6. Germany pubmed.ncbi.nlm.nih.gov

[Repetitive transcranial magnetic stimulation. A reasonable adjuvant therapeutic method in the treatment of post-stroke aphasia?]. [2021] Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, painless method used to stimulate areas of the brain through the intact skull by means of magnetic fields. Depending on the stimulation frequency, the effect on concurrent brain areas is either inhibiting or exciting. As a result, it should be possible to inhibit compensatory hyperactivation in certain brain areas or to temporarily enhance cortical excitability. Therefore, rTMS potentially represents an adjuvant treatment for aphasia. In this article, the literature regarding rTMS as a treatment for aphasia is reviewed and followed by a case report of a 79-year-old man who 3 years after stroke received rTMS (3 × 10 sessions) in combination with articulation therapy. Even though linguistic assessments did not show enhancements in language skills, the patient's family reported changes in communication patterns and behavior and explicitly asked to continue the rTMS treatment sessions. Reasons why no enhancements could be reported might be found in the type of language disorder (a comorbid speech disorder) or the stimulation protocol. Further studies are needed to evaluate the true potential of rTMS in the treatment of aphasia.

7. United States 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. [2021] Objective The aim of the study was to investigate the effectiveness and safety of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) in patients with poststroke aphasia. Method We comprehensively searched for eligible studies from 11 electronic medical databases from their inception to February 20, 2019. Randomized controlled trials reporting the effectiveness of LF-rTMS for patients with poststroke aphasia were included. The primary outcome was language ability. The secondary outcomes were functional communication and adverse events. The methodological quality of the randomized controlled trials was evaluated by the Cochrane Back Review Group Risk of Bias Assessment Criteria. Results Of the 567 records retrieved, 18 studies with a total of 536 participants were included. All the included studies were of relatively acceptable methodological quality. All studies but one used LF-rTMS + speech and language therapy (SLT), not LF-rTMS alone. The meta-analysis showed that LF-rTMS had beneficial effects for patients with aphasia after a stroke in terms of naming, repetition, comprehension, written language, and functional communication. The subgroup analyses of language performance showed positive effects of LF-rTMS among stroke patients with chronic aphasia and acute aphasia. LF-rTMS + SLT had effects on language performance that were superior to the sham rTMS + SLT and SLT alone. A shorter LF-rTMS duration benefited language performance more than a longer duration. Additionally, 20 min of LF-rTMS per session produced a positive effect on language ability for patients with aphasia after a stroke. No adverse events were reported. Conclusions LF-rTMS + SLT is an effective and safe method for patients with poststroke aphasia to improve their language performance. Additionally, the most commonly used LF-rTMS protocol for patients with aphasia after a stroke was 90% of the resting motor threshold 20 min per day, 5 days per week, for 2 weeks.

8. Netherlands 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. [2023] Repetitive transcranial magnetic stimulation (rTMS) shows promise in improving speech production in post-stroke aphasia. Limited evidence suggests pairing rTMS with speech therapy may result in greater improvements. Twenty stroke survivors (>6 months post-stroke) were randomized to receive either sham rTMS plus multi-modality aphasia therapy (M-MAT) or rTMS plus M-MAT. For the first time, we demonstrate that rTMS combined with M-MAT is feasible, with zero adverse events and minimal attrition. Both groups improved significantly over time on all speech and language outcomes. However, improvements did not differ between rTMS or sham. We found that rTMS and sham groups differed in lesion location, which may explain speech and language outcomes as well as unique patterns of BOLD signal change within each group. We offer practical considerations for future studies and conclude that while combination therapy of rTMS plus M-MAT in chronic post-stroke aphasia is safe and feasible, personalized intervention may be necessary.

9. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of rTMS in patients with poststroke aphasia: a systematic review and focused meta-analysis. [2022] Aphasia-acquired loss of the ability to understand or express language-is a common and debilitating neurological consequence of stroke. Evidence suggests that transcranial magnetic stimulation (TMS) can significantly improve language outcomes in patients with aphasia. Repetitive transcranial magnetic stimulation (rTMS) has been reported to improve naming in chronic stroke patients with nonfluent aphasia since 2005.

10. Switzerland 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. [2022] Although low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) has shown promise in the treatment of poststroke aphasia, the efficacy of high-frequency rTMS (HF-rTMS) has yet to be determined.