Brain Stimulation for Dyslexia

Overseen By C.Nikki Arrington, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Must not be taking: Seizure threshold-lowering drugs

Disqualifiers: Autism, Hearing deficits, Seizure 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: 5

Duration: 2 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability.

Will I have to stop taking my current medications?

The trial excludes individuals taking certain medications that lower the seizure threshold, so you may need to stop taking those specific medications. The protocol does not specify other medication restrictions.

What data supports the effectiveness of the treatment Transcranial Magnetic Stimulation for dyslexia?

Research shows that high frequency repetitive transcranial magnetic stimulation (hf-rTMS) can improve reading skills in adults with dyslexia by enhancing reading speed and accuracy. This treatment targets specific brain areas that are underactive in dyslexics, leading to better reading 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, and while it is generally considered safe, it has been associated with some risks, such as seizures. Guidelines have been developed to ensure its safe use, and it is important to follow recommended limits and monitoring procedures during treatment. ^{1 6 7 8 9}

How does the treatment Transcranial Magnetic Stimulation (rTMS) for dyslexia differ from other treatments?

Transcranial Magnetic Stimulation (rTMS) is unique because it uses magnetic fields to stimulate specific brain areas that are underactive in people with dyslexia, potentially improving reading skills by enhancing neural pathways. Unlike traditional methods, it directly targets brain function rather than focusing solely on behavioral interventions. ^{1 2 10 11 12}

Eligibility Criteria

This trial is for older youth with dyslexia. Participants should be able to undergo brain stimulation and are interested in how it might affect learning new spoken words. Specific eligibility details aren't provided, so generally healthy individuals who meet the age requirement for 'older youth' may apply.

Inclusion Criteria

My vision is normal or corrected to normal with glasses or contacts.

Native English speaker (who is not fluent in any other language and does not identify as bilingual)

Exclusion Criteria

Individuals with MRI Screening and Contraindication Forms which do not pass MRI Tech review

Diagnosed with Autism Spectrum Disorder

Individuals with TMS Screening and Contraindication Forms which do not pass TMS Tech review

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI

Participants complete a baseline MRI session to assess the reading and language network

1 week

1 visit (in-person)

Treatment

Participants receive cTBS or sham stimulation followed by pseudoword discrimination and word learning tasks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for retention of learned items 24 hours after each treatment session

2 weeks

2 visits (in-person)

Treatment Details

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study tests if a type of brain stimulation called cTBS can influence learning, processing, and remembering made-up words that sound similar. Some participants will receive real cTBS while others get a sham (fake) treatment to compare results.

Participant Groups

Group I: Active cTBS Experimental Treatment 1 Intervention

Active cTBS will be administered to the left supramarginal gyrus

Group II: Sham stimulation Placebo Group 1 Intervention

Sham stimulation will be administered to the left supramarginal gyrus

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?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

High frequency repetitive transcranial magnetic stimulation (hf-rTMS) applied to specific brain areas in dyslexic adults showed significant improvements in reading performance, with stimulation over the left inferior parietal lobule enhancing non-word reading accuracy and the left superior temporal gyrus increasing word reading speed and text reading accuracy.

The study also revealed that stimulation of the right inferior parietal lobule contributed to improved non-word reading accuracy, suggesting that dyslexics may recruit additional brain regions to compensate for reading difficulties, indicating potential pathways for developing long-term treatments for dyslexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to improve reading skills in dyslexics: the effect of high frequency rTMS. Costanzo, F., Menghini, D., Caltagirone, C., et al.[2013]

A study using Transcranial Magnetic Stimulation (TMS) on a patient with acquired dyslexia showed that stimulating the right hemisphere disrupted their ability to read aloud, supporting the idea that the right hemisphere can mediate some reading abilities in patients with dominant hemisphere damage.

This finding suggests that even in cases of dyslexia, the right hemisphere may play a crucial role in reading, challenging the traditional view that reading is solely a function of the left hemisphere.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reading with the right hemisphere: evidence from transcranial magnetic stimulation. Coslett, HB., Monsul, N.[2015]

In a study of 22 patients with acute ischaemic stroke, active repetitive transcranial magnetic stimulation (rTMS) significantly improved dysphagia compared to sham treatment, indicating its potential effectiveness in treating swallowing difficulties after brainstem infarctions.

The improvements in dysphagia were sustained for up to 2 months, suggesting that rTMS could be a valuable addition to rehabilitation strategies for patients with lateral medullary infarction and other brainstem strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic role of rTMS on recovery of dysphagia in patients with lateral medullary syndrome and brainstem infarction. Khedr, EM., Abo-Elfetoh, N.[2017]

In a study involving seven nonfluent aphasic participants, repetitive transcranial magnetic stimulation (rTMS) applied over a 10-day period led to significant improvements in language abilities, including picture naming and auditory comprehension, with effects lasting up to 8 months.

The findings support the idea that rTMS can enhance language retrieval mechanisms in individuals with chronic aphasia, indicating its potential as a valuable rehabilitation tool following left hemisphere stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved receptive and expressive language abilities in nonfluent aphasic stroke patients after application of rTMS: an open protocol case series. Barwood, CHS., Murdoch, BE., Whelan, BM., et al.[2018]

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]

Repetitive transcranial magnetic stimulation (rTMS) is a powerful tool that can effectively treat clinical depression and potentially other brain disorders, but it carries risks, including the potential to induce seizures, as evidenced by 7 known cases by 1996.

A workshop established safety guidelines for rTMS, emphasizing the importance of monitoring, ethical considerations, and the expertise required for its administration to minimize risks and enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Wassermann, EM.[2022]

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 not been thoroughly studied for side effects, with the main known risk being the acute production of seizures.

While tissue damage from rTMS is unlikely, there are concerns about potential cognitive effects and the possibility of long-term changes in brain function that have not yet been fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of repetitive transcranial magnetic stimulation. Wassermann, EM.[2005]

Repetitive transcranial magnetic stimulation (rTMS) is generally a well-tolerated treatment for depression, with mild side effects like headaches being the most common, while severe adverse effects are rare.

Special precautions are necessary for certain groups, such as adolescents, pregnant women, and individuals with metal implants, but with proper assessment and monitoring, rTMS can be safely administered to many patients with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. Taylor, R., Galvez, V., Loo, C.[2019]

Eighteen children and adolescents with dyslexia underwent 18 sessions of transcranial direct current stimulation (tDCS) combined with cognitive training, resulting in significant improvements in reading low frequency words and non-words, with effects lasting one month after treatment.

The study found no adverse effects from the tDCS treatment, indicating it is a safe and feasible option for enhancing reading abilities in children and adolescents with dyslexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for reading improvement following tDCS treatment in children and adolescents with Dyslexia. Costanzo, F., Varuzza, C., Rossi, S., et al.[2018]

Transcranial magnetic stimulation (TMS) applied to the left temporo-parietal cortex (TPC) in 28 typical adult readers showed that it can induce changes in brain activation patterns, particularly increasing connectivity between the left ventral occipito-temporal cortex and the left TPC, which are crucial for reading.

Although TMS did not improve reading performance, the study demonstrated that TMS can lead to short-term compensatory reorganization in the reading network, suggesting potential for targeted interventions in individuals with dyslexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive short-term plasticity in the typical reading network. Turker, S., Kuhnke, P., Schmid, FR., et al.[2023]

Noninvasive brain stimulation (NIBS) combined with reading training has shown promise in improving reading performance in both children and adults with dyslexia, based on a review of 15 studies.

Targeting classical reading areas with NIBS can enhance various reading-related skills, and there is potential for modulating auditory cortex function to prevent phonological difficulties associated with dyslexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of noninvasive brain stimulation techniques to improve reading difficulties in dyslexia: A systematic review. Turker, S., Hartwigsen, G.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

How to improve reading skills in dyslexics: the effect of high frequency rTMS. [2013]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Reading with the right hemisphere: evidence from transcranial magnetic stimulation. [2015]

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

Therapeutic role of rTMS on recovery of dysphagia in patients with lateral medullary syndrome and brainstem infarction. [2017]

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

Improved receptive and expressive language abilities in nonfluent aphasic stroke patients after application of rTMS: an open protocol case series. [2018]

5. 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]

6. Ireland pubmed.ncbi.nlm.nih.gov

Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. [2022]

7. 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]

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

Side effects of repetitive transcranial magnetic stimulation. [2005]

9. England pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation (TMS) safety: a practical guide for psychiatrists. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Evidence for reading improvement following tDCS treatment in children and adolescents with Dyslexia. [2018]

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

Adaptive short-term plasticity in the typical reading network. [2023]

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

The use of noninvasive brain stimulation techniques to improve reading difficulties in dyslexia: A systematic review. [2023]