TMS + Language Therapy for Aphasia

(TMS Trial)

Overseen By Daniela Sacchetti, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Disqualifiers: Substance abuse, Neurological disorders, Psychiatric disorders, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with Speech-Language Therapy (SLT) is an effective treatment for mild aphasia in persons with chronic stroke. The main questions this study aims to answer are: 1. Can TMS combined with SLT improve conversational speech and comprehension? 2. Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and SLT treatment? Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat post-stroke mild aphasia. Participants will: * Complete a screening and medical intake to determine eligibility * Undergo a MRI * Participate in 10 consecutive sessions (Monday-Friday) of TMS and SLT treatment * Complete follow-up assessments 2 and 4 months after treatment

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 coordinators or your doctor.

Is TMS combined with language therapy safe for humans?

Studies show that combining transcranial magnetic stimulation (TMS) with language therapy is generally safe for people who have had a stroke, with no reported serious side effects. ^{1 2 3 4 5}

How does the TMS + Language Therapy treatment for aphasia differ from other treatments?

The TMS + Language Therapy treatment for aphasia is unique because it combines transcranial magnetic stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain, with language therapy to improve language skills in stroke patients. This approach is different from traditional speech therapy alone, as TMS may enhance the brain's ability to recover language function by targeting specific brain areas. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment TMS + Language Therapy for Aphasia?

Research shows that combining repetitive transcranial magnetic stimulation (rTMS) with speech therapy can improve communication and language skills in people with aphasia after a stroke. Studies indicate that this combination is safe and may enhance speech production and naming abilities. ^{1 2 5 6 9}

Who Is on the Research Team?

H. Branch Coslett, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals with mild aphasia due to chronic stroke. Participants must complete a medical screening, be eligible based on their MRI results, and commit to 10 consecutive sessions of treatment along with follow-up assessments.

Inclusion Criteria

My stroke happened over 6 months ago.

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

Mild Aphasia (WAB AQ score > 85)

Exclusion Criteria

I have been diagnosed with tinnitus.

Ongoing substance or alcohol abuse

Active psychiatric disorders (e.g., bipolar disorder, schizophrenia)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a battery of tests to define their language function and a research MRI scan

1 week

1 visit (in-person)

Treatment

Participants receive 10 consecutive sessions of TMS and SLT treatment over 2 weeks

2 weeks

10 visits (in-person)

Follow-up

Participants complete follow-up assessments to monitor language functioning

4 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Speech-Language Therapy
• Transcranial Magnetic Stimulation

Trial Overview The study tests if Transcranial Magnetic Stimulation (TMS) combined with Speech-Language Therapy (SLT) can improve speech and comprehension in people with mild aphasia from stroke. It compares real TMS against sham TMS over two weeks of daily sessions.

How Is the Trial Designed?

Group I: Real TMS Experimental Treatment 2 Interventions

Some of our participants will be randomized to the real treatment arm where they will receive 10 sessions of real TMS paired with speech-language therapy.

Group II: Fake TMS Placebo Group 1 Intervention

Some of our participants will be randomized to the sham treatment arm where they will receive 10 sessions of fake TMS paired with speech-language therapy.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Temple University

Collaborator

Trials

321

Recruited

89,100+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

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) 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]

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]

In a study involving 30 participants with subacute aphasia after stroke, those who received real repetitive transcranial magnetic stimulation (rTMS) combined with speech therapy showed significant improvements in all 10 measures of basic linguistic skills and functional communication, compared to only 6 measures in the sham group.

This research indicates that combining rTMS with behavioral language therapy can effectively enhance communication abilities in patients with subacute aphasia, marking a promising advancement in rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Add-on Effects of Repetitive Transcranial Magnetic Stimulation on Subacute Aphasia Therapy: Enhanced Improvement of Functional Communication and Basic Linguistic Skills. A Randomized Controlled Study. Rubi-Fessen, I., Hartmann, A., Huber, W., et al.[2022]

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]

The combination of 6-Hz-primed low-frequency rTMS and intensive speech therapy was safely administered to four post-stroke patients without any adverse effects during an 11-day treatment period.

All patients showed significant improvements in language function, indicating that this treatment protocol may be an effective option for enhancing recovery in individuals with post-stroke aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic application of 6-Hz-primed low-frequency rTMS combined with intensive speech therapy for post-stroke aphasia. Kakuda, W., Abo, M., Momosaki, R., et al.[2016]

The study involved two post-stroke patients with sensory-dominant aphasia who underwent 10 sessions of low-frequency rTMS targeting the Wernicke's area, combined with language therapy, demonstrating that this approach is safe and well-tolerated without adverse effects.

Both patients showed significant improvements in language function, as measured by the Token test and Standard Language Test of Aphasia, with benefits persisting for three months after treatment, indicating the efficacy of this combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-frequency rTMS with language therapy over a 3-month period for sensory-dominant aphasia: case series of two post-stroke Japanese patients. Kakuda, W., Abo, M., Uruma, G., et al.[2022]

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]

In a study of 17 patients with chronic post-stroke aphasia, Intensive Language-Action Therapy (ILAT) significantly improved language performance, as measured by various tests, regardless of whether patients received real or sham transcranial magnetic stimulation (TMS).

The study found no significant benefit of TMS when combined with ILAT, suggesting that while ILAT is effective for language rehabilitation, TMS may not enhance its effects in chronic aphasia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining rTMS With Intensive Language-Action Therapy in Chronic Aphasia: A Randomized Controlled Trial. Heikkinen, PH., Pulvermüller, F., Mäkelä, JP., et al.[2020]

Citations

1. 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]

2. 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]

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

Transcranial magnetic stimulation and aphasia rehabilitation. [2021]

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

Add-on Effects of Repetitive Transcranial Magnetic Stimulation on Subacute Aphasia Therapy: Enhanced Improvement of Functional Communication and Basic Linguistic Skills. A Randomized Controlled Study. [2022]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Therapeutic application of 6-Hz-primed low-frequency rTMS combined with intensive speech therapy for post-stroke aphasia. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Low-frequency rTMS with language therapy over a 3-month period for sensory-dominant aphasia: case series of two post-stroke Japanese patients. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of rTMS in patients with poststroke aphasia: a systematic review and focused meta-analysis. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Combining rTMS With Intensive Language-Action Therapy in Chronic Aphasia: A Randomized Controlled Trial. [2020]