Transcranial Magnetic Stimulation + Language Therapy for Aphasia

Overseen By Daniela Sacchetti, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Disqualifiers: Substance abuse, Psychiatric illness, Dementia, Epilepsy, 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: 14

Duration: 2 weeks

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining Transcranial Magnetic Stimulation (TMS) with language therapy can improve speech in individuals with aphasia following a stroke. Researchers seek to establish whether real TMS produces better outcomes than a sham version, tailoring the TMS intensity and targeting for each participant. Individuals who have experienced a stroke affecting the left side of the brain and have difficulty speaking may be suitable candidates, particularly if the stroke occurred within the last 2 to 6 weeks. Participants will undergo MRI scans and participate in ten treatment sessions over two weeks, with follow-up assessments immediately after and four months later. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

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.

What prior data suggests that this treatment is safe for aphasia patients?

Studies have shown that Transcranial Magnetic Stimulation (TMS) is generally safe for people. TMS already treats conditions like depression and speech problems after a stroke. Research suggests that TMS can improve speech, particularly in understanding spoken words, for those with post-stroke speech issues.

In past studies, patients tolerated TMS well, with no serious side effects reported. Some experienced minor side effects like headaches or discomfort at the treatment site, but these were temporary. The researchers strictly follow safety guidelines to ensure TMS remains a safe treatment option.

TMS uses magnetic fields to stimulate brain cells. As a non-invasive treatment, it doesn't involve surgery, making it appealing to many patients. The current trial is in an early stage, so researchers are still collecting information on its safety and effectiveness. However, TMS's use in other conditions provides some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for aphasia?

Researchers are excited about using Transcranial Magnetic Stimulation (TMS) for treating aphasia because it targets the brain directly with magnetic pulses to stimulate neural activity, offering a novel approach compared to traditional speech and language therapy. Unlike conventional treatments, which primarily focus on exercises and practice to improve language skills, TMS aims to physically enhance brain function by activating specific brain regions involved in language. This method has the potential to accelerate recovery and improve language abilities more effectively, providing new hope for individuals with aphasia.

What evidence suggests that Transcranial Magnetic Stimulation combined with language therapy is effective for treating aphasia?

Research has shown that Transcranial Magnetic Stimulation (TMS) may help treat aphasia, a language disorder often caused by a stroke. Studies have found that TMS can significantly improve language skills in stroke patients, enhancing communication. In this trial, some participants will receive real TMS paired with language therapy, while others will receive sham TMS as a comparator. One study found that TMS combined with language therapy improved a key language test score in patients more than six months after a stroke. Another study demonstrated that TMS had both immediate and long-lasting positive effects on language recovery after a stroke. These findings suggest that TMS, especially when combined with therapy, could effectively help aphasia patients improve their speech. ^{2 3 6 7 8}

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 who have had a stroke and are experiencing aphasia, which affects their ability to communicate. They must be in the subacute stage after their stroke and able to undergo MRI scans. Participants will need to commit to daily sessions over two weeks and follow-up assessments.

Inclusion Criteria

English proficiency

Right-handed

I had a stroke in the left side of my brain causing speech difficulties.

Exclusion Criteria

I've had a head injury that knocked me out for over 5 minutes.

Pregnancy

History of serious and/or ongoing issues with substance abuse

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 MRI scans and a battery of tests to define their language function

1 week

1 visit (in-person)

Treatment

Participants receive 10 consecutive sessions of TMS and mCILT treatment

2 weeks

10 visits (in-person)

Immediate Follow-up

Participants complete follow-up assessments immediately after treatment

1 week

1 visit (in-person)

Long-term Follow-up

Participants are monitored for language function 4 months after treatment

4 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Modified Constraint Induced Language Therapy (mCILT)
• Transcranial Magnetic Stimulation (TMS)

Trial Overview The study tests if Transcranial Magnetic Stimulation (TMS) combined with modified Constraint Induced Language Therapy (mCILT) can improve speech in people with aphasia post-stroke. It compares real TMS with sham TMS, using electric field guided technology for personalized treatment intensity and targeting.

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 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 language therapy.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39999397/

Transcranial Magnetic Stimulation Combined With ... This study provides Class III evidence that in patients with aphasia 6 or more months after a stroke, 1-Hz rTMS combined with intensive M-MAT improves WAB-AQ ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837379

Long-Term Therapy With Transcranial Magnetic ... Findings In this randomized clinical trial, which included 63 participants diagnosed with PPA, TMS administered over a 6-month period mitigated ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999323006597

The Therapeutic Effect of Transcranial Magnetic ... The results showed that TMS treatment has significant immediate (Hedges' g=0.37) and maintenance (Hedges' g=0.34) effects on post-stroke aphasia. Additionally, ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000213424

Transcranial Magnetic Stimulation Combined With ... This study provides Class III evidence that in patients with aphasia 6 or more months after a stroke, 1-Hz rTMS combined with intensive M-MAT improves WAB-AQ ...

5. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2020_JSLHR-19-00077

Systematic Review and Meta-Analysis of Its Effect Upon ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3589757/

Transcranial Magnetic Stimulation and Aphasia Rehabilitation Given the extensive safety data and the strict adherence of our study protocol to current safety guidelines and recommendations endorsed by the ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1614586/full

Efficacy and safety of repetitive transcranial magnetic ... This study shows that rTMS can safely and effectively improve speech function in patients with post-stroke aphasia (PSA), particularly in auditory comprehension ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1052305721002585

Effect of High Frequency Transcranial Magnetic Stimulation ... Excitatory rTMS protocol appeared to be a safe modality, thus it should be further tested in blinded studies on larger sample size assessing its safety and ...