TMS for Speech

Overseen By Carrie Niziolek, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Epileptogenic medications, Illegal drugs

Disqualifiers: Neurological disorders, Hearing disorders, 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

Duration: 3 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to understand how the brain processes and controls speech in healthy people. The investigators are doing this research because it will help identify the mechanisms that allow people to perceive their own speech errors and to learn new speech sounds, which may be applied to people who have communication disorders. 15 participants will be enrolled into this part of the study and can expect to be on study for 4 visits of 2-4 hours each.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that increase the risk of seizures or are considered 'epileptogenic,' you may not be eligible to participate.

What data supports the effectiveness of the treatment TMS for Speech?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve speech and language skills in people with conditions like Parkinson's disease and after a stroke. Studies have found that rTMS, when combined with speech therapy, enhances communication abilities and motor speech performance. ^{1 2 3 4 5}

Is repetitive Transcranial Magnetic Stimulation (rTMS) safe for humans?

Repetitive Transcranial Magnetic Stimulation (rTMS) has been studied for safety in various conditions, including depression and post-stroke aphasia. Studies have shown that rTMS is generally safe, with reports of zero adverse events in some trials, making it a feasible option for therapy. ^{1 6 7 8 9}

How is the TMS treatment for speech different from other treatments?

Transcranial Magnetic Stimulation (TMS) for speech is unique because it uses magnetic fields to stimulate specific areas of the brain involved in speech, which can help in understanding and potentially treating speech disorders. Unlike traditional speech therapies, TMS directly targets brain activity, offering a novel approach to modulating speech-related functions. ^{7 10 11 12 13}

Research Team

Carrie Niziolek, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for healthy individuals interested in how the brain controls speech. Participants should be available for 4 visits, each lasting 2-4 hours. The eligibility criteria are not fully listed here, so potential participants would need to contact the researchers for more details.

Inclusion Criteria

I have never had a stroke or neurological conditions.

I can hear and speak normally.

Exclusion Criteria

My family has a history of epilepsy.

Vulnerable populations (minors and prisoners)

Implanted paramagnetic materials (metal clips, plates, pacemakers, etc.)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo transcranial magnetic stimulation (TMS) sessions targeting the primary somatosensory cortex using iTBS, cTBS, and sham stimulation.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in speech production and sensory adaptation after TMS sessions.

1 week

Treatment Details

Interventions

• TMS

Trial Overview The study is testing the effects of Transcranial Magnetic Stimulation (TMS) on speech processing and control during speaking tasks. It aims to understand how people perceive their own speech errors and learn new sounds.

Participant Groups

Group I: Healthy Adult Speakers Experimental Treatment 2 Interventions

healthy adult participants across the lifespan in three groups:18-35, 36-55, and 56+

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Findings from Research

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]

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]

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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of articulatory dysfunction in Parkinson's disease using repetitive transcranial magnetic stimulation. [2015]

3. 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]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Repetitive Transcranial Magnetic Stimulation on Patients With Dysarthria After Subacute Stroke. [2020]

5. Denmark pubmed.ncbi.nlm.nih.gov

rTMS as a treatment for neurogenic communication and swallowing disorders. [2013]

6. 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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Speech arrest by repetitive Transcranial Magnetic Stimulation - does it still work? Old experiences with new improvements. [2022]

8. United States 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. [2019]

9. 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]

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

Cortical Inhibition of Face and Jaw Muscle Activity and Discomfort Induced by Repetitive and Paired-Pulse TMS During an Overt Object Naming Task. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Localization and characterization of speech arrest during transcranial magnetic stimulation. [2019]

12. Denmark pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on voice and speech in Parkinson's disease. [2007]

13. Netherlands pubmed.ncbi.nlm.nih.gov

A novel approach for documenting naming errors induced by navigated transcranial magnetic stimulation. [2012]