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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial magnetic stimulation (TMS) can influence how older youth learn and remember new words. TMS is a non-invasive method that uses magnetic fields to stimulate the brain. The study compares the effects of real and sham (fake) stimulation on word learning. Ideal participants are native English speakers with normal or corrected vision who do not have autism, certain hearing or vision deficits, or metal in their body. As an unphased trial, this study allows participants to contribute to groundbreaking research in cognitive science.

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 prior data suggests that transcranial magnetic stimulation is safe for older youth?

Research has shown that transcranial magnetic stimulation (TMS) affects reading and dyslexia by targeting specific brain areas. For example, studies have demonstrated that TMS can explore questions about dyslexia without significant safety concerns.

Regarding safety, TMS typically causes only minor side effects. In one study with ADHD patients, TMS improved symptoms with only minor side effects reported. Additionally, any discomfort from TMS usually resolves quickly.

Overall, TMS appears well-tolerated with minor side effects in these studies, suggesting a similar level of safety might be expected in trials exploring TMS for dyslexia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional dyslexia treatments, which often focus on educational interventions and supportive therapies, transcranial magnetic stimulation (TMS) offers a novel approach by directly targeting the brain's neural activity. This treatment is unique because it uses magnetic fields to stimulate the left supramarginal gyrus, a brain area linked with language processing, potentially reshaping neural pathways to improve reading skills. Researchers are excited about TMS because it could provide a non-invasive, quick-acting alternative with the potential for lasting effects, bypassing the lengthy and sometimes limited impact of conventional methods.

What evidence suggests that transcranial magnetic stimulation is effective for dyslexia?

Studies have shown that Transcranial Magnetic Stimulation (TMS) can impact reading skills. Specifically, applying TMS to brain areas involved in reading leads to faster reading of pseudowords, which are made-up words that follow normal spelling rules. Research indicates that TMS in certain brain areas also improves reading accuracy for these non-words. In this trial, participants will receive either active cTBS or sham stimulation to the left supramarginal gyrus. These findings suggest that TMS could be a promising method to address reading difficulties like dyslexia by altering how the brain processes written language. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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Brain Stimulation for Dyslexia

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