Brain Stimulation for Language Disorder

Overseen By Matthew Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Age less than 18

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

Compensation: Varies

Number of Visits: Unknown

153 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how brain stimulation might affect language comprehension in people with epilepsy. Researchers will record participants' brain activity while they read or listen to sentences. Later, some participants will receive brief electrical stimulation (also known as direct brain stimulation) to observe its influence on their understanding. The trial aims to link changes in brain activity with improvements or changes in language processing. This study suits individuals with epilepsy who are already undergoing brain monitoring as part of their treatment. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance language comprehension therapies for epilepsy patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this brain stimulation is safe for language disorder treatment?

Research has shown that non-invasive brain stimulation, similar to that used in this trial, is generally safe. Specifically, transcranial direct current stimulation (tDCS) is safe and painless. It uses gentle electrical currents to enhance language skills in stroke survivors.

Studies have found that tDCS, when combined with speech therapy, aids language recovery with few side effects. Most people tolerate this type of brain stimulation well, experiencing little to no discomfort. Although the stimulation in this trial differs slightly, research supports the overall safety of brain stimulation methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for brain stimulation for language disorder because it explores a new technique that could revolutionize treatment. Unlike current therapies that often focus on speech therapy or medication, this approach involves intracranial stimulation, directly interacting with brain activity. By stimulating specific brain areas while recording their responses, this method has the potential to more precisely target the neural pathways involved in language processing. This could lead to more effective and faster improvements in language abilities for people with disorders that current treatments struggle to address.

What evidence suggests that this trial's treatments could be effective for language disorder?

Research has shown that direct brain stimulation, such as transcranial direct current stimulation (tDCS), may help improve language skills. Some studies found that tDCS can aid language recovery for people with aphasia, a language disorder that can occur after a stroke. It appears to work by making the brain more receptive to therapy, potentially enhancing speech and naming abilities. In this trial, participants with epilepsy undergoing intracranial monitoring will participate in experiments that include stimulation with simultaneous recording. Although this study focuses on epilepsy, the technology could also assist with language disorders by improving how the brain processes language during stimulation. These early findings suggest that brain stimulation might be a useful tool for enhancing language understanding and processing. ^{1 4 6 7 8}

Who Is on the Research Team?

Matthew Nelson, MD

Principal Investigator

The University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 18 with language disorders who are already undergoing brain monitoring (sEEG or ECoG) for epilepsy. Participants must be able to perform control trials of the task effectively.

Inclusion Criteria

I am currently receiving standard brain monitoring.

I can competently perform the required tasks for the study.

Exclusion Criteria

I cannot perform certain tasks accurately on my own.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recording-only task

Participants perform language tasks requiring comprehension and response while neural activity is recorded.

1 hour per session

Multiple sessions during hospital stay

Stimulation task

Participants perform language tasks with controlled electrical stimulation to examine effects on comprehension and neural activity.

1 hour per session

Multiple sessions during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Direct brain stimulation
• Sentence Type

Trial Overview The study tests how sentence types and direct brain stimulation affect language comprehension. Patients read or listen to sentences while their neural activity is recorded, then choose pictures matching the sentences. Later, some receive brain stimulation during this task.

How Is the Trial Designed?

Group I: Intracranial patients Experimental Treatment 2 Interventions

All participants with epilepsy undergoing intracranial monitoring for clinical purposes will be approached to participate in an experiment that is recording-only and an experiment that involves stimulation with simultaneous recording.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

A 12-week language treatment program for 10 individuals with aphasia improved their ability to process passive sentences, leading to more typical eye movement patterns during sentence comprehension tasks.

Post-treatment, participants showed enhanced predictive processing and thematic analysis for both active and passive sentences, indicating that targeted therapy can effectively support normal-like sentence comprehension processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of Online Sentence Processing in Aphasia: Eye Movement Changes Resulting From Treatment of Underlying Forms. Mack, JE., Thompson, CK.[2018]

In a study involving two patients with chronic nonfluent aphasia, one patient (G01) showed significant improvement in sentence production and increased activity in Broca's area after treatment, indicating effective engagement of neural substrates for syntax production.

The other patient (J02) did not show similar improvements, suggesting that treatment effects can vary greatly between individuals, potentially due to differences in how their brains utilize existing neural pathways for language tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural substrates of syntactic mapping treatment: an fMRI study of two cases. Wierenga, CE., Maher, LM., Moore, AB., et al.[2007]

In a study involving 6 subjects undergoing awake surgery, stimulation of the inferior frontal gyrus disrupted comprehension of complex passive sentences, highlighting its critical role in syntactic processing.

The results indicate that specific language regions, particularly the pars opercularis, are essential for understanding sentence-level tasks, suggesting that these areas should be targeted in future research on language processing and surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating syntactic comprehension during awake intraoperative cortical stimulation mapping. Riva, M., Wilson, SM., Cai, R., et al.[2023]

A comprehensive analysis of 45 studies identified a network in the brain, primarily in the bilateral frontal and temporal lobes, that is crucial for both understanding and producing sentences.

Differences were noted between auditory and visual sentence comprehension, particularly in the temporal lobes, and complex syntactic sentences engaged additional regions, including the right insula, suggesting that right hemisphere involvement may be important for language recovery in patients with agrammatic aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural networks for sentence comprehension and production: An ALE-based meta-analysis of neuroimaging studies. Walenski, M., Europa, E., Caplan, D., et al.[2020]

In a study involving 14 patients undergoing left-hemisphere neurosurgery, cortical stimulation mapping revealed nine specific sites in the inferior frontal gyrus that selectively interfered with syntactic encoding during sentence production, without affecting single word processing.

The types of interference observed included errors in grammatical roles and omissions of function words, highlighting the critical role of the left inferior frontal gyrus in constructing syntactic structure in language.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective Interference with Syntactic Encoding during Sentence Production by Direct Electrocortical Stimulation of the Inferior Frontal Gyrus. Chang, EF., Kurteff, G., Wilson, SM.[2019]

Anodal stimulation of the left lateral prefrontal cortex significantly improved performance in tasks requiring executive control, such as processing ambiguous sentences and complex memory tasks, compared to sham and cathodal stimulation.

This study provides evidence that brain stimulation can effectively reduce cognitive processing demands during language tasks, highlighting the left lateral prefrontal cortex's crucial role in executive control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Language and Memory Improvements following tDCS of Left Lateral Prefrontal Cortex. Hussey, EK., Ward, N., Christianson, K., et al.[2020]

Non-invasive brain stimulation techniques, particularly low-frequency rTMS and cathodal tDCS, can significantly improve naming accuracy in patients with post-stroke aphasia, as shown in a meta-analysis of nine trials with 215 participants, yielding a moderate effect size of 0.51.

The application of these techniques to the non-language dominant hemisphere may promote neural reorganization and reduce competition between brain hemispheres, suggesting a promising adjunct to conventional speech and language therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory non-invasive brain stimulation to homologous language regions as an adjunct to speech and language therapy in post-stroke aphasia: a meta-analysis. Otal, B., Olma, MC., Flöel, A., et al.[2022]

Transcranial direct current stimulation (tDCS) combined with speech and language treatment (SLT) is safe for stroke survivors with aphasia, showing no serious adverse events during a six-week treatment involving 30 sessions.

Participants receiving active tDCS exhibited greater improvements in functional language compared to those receiving sham treatment, suggesting that tDCS may enhance the effectiveness of SLT, although the superiority of one stimulation polarity over another remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended fMRI-Guided Anodal and Cathodal Transcranial Direct Current Stimulation Targeting Perilesional Areas in Post-Stroke Aphasia: A Pilot Randomized Clinical Trial. Cherney, LR., Babbitt, EM., Wang, X., et al.[2021]

The combination of dual transcranial direct current stimulation (tDCS) and speech language therapy significantly improved linguistic deficits in a stroke patient with left brain damage, particularly enhancing reading and writing skills.

This approach not only improved specific language tasks, like reading non-words, but also positively affected overall communication quality and other cognitive functions, suggesting a broad therapeutic benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rehabilitative effects on written language of a combined language and parietal dual-tDCS treatment in a stroke case. De Tommaso, B., Piedimonte, A., Caglio, MM., et al.[2018]

Noninvasive brain stimulation (NIBS), including techniques like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), has shown promise in enhancing cognitive functions and inducing adaptive plasticity in both motor and cognitive networks.

Recent advances suggest that combining NIBS with neuroimaging or electrophysiological techniques can effectively modulate neural activity in the language network, which may aid in language recovery for individuals with poststroke aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive Plasticity in the Healthy Language Network: Implications for Language Recovery after Stroke. Hartwigsen, G.[2018]

In a study involving 12 patients with chronic post-stroke aphasia, anodal transcranial direct current stimulation (tDCS) significantly improved naming abilities after language training compared to sham stimulation, indicating its potential to enhance treatment outcomes.

The benefits of anodal tDCS were maintained for at least 2 weeks post-training, and patients' baseline naming ability was a predictor of how well they responded to the stimulation, suggesting that individual differences may influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term anomia training and electrical brain stimulation. Flöel, A., Meinzer, M., Kirstein, R., et al.[2016]

Electrical stimulation of cortical and sub-cortical areas of the brain can significantly impact language and speech functions, suggesting a direct relationship between brain activity and verbal abilities.

The study also reviews the effects of surgical procedures, such as resections or coagulations, that follow electrical stimulation, highlighting the potential consequences on verbal communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of electrostimulation and of resective and stereotactic surgery on language and speech. Lebrun, Y., Leleux, C.[2019]

The study analyzed naming errors in patients undergoing cortical stimulation mapping (CSM) to identify essential language areas, revealing a variety of errors such as semantic paraphasias and phonological paraphasias, which indicate a complex and distributed cortical network involved in language processing.

Using advanced web-based tools, the research mapped the locations of these errors, contributing to our understanding of how different brain regions (frontal, parietal, and temporal) are involved in language comprehension and production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of naming errors during cortical stimulation mapping: implications for models of language representation. Corina, DP., Loudermilk, BC., Detwiler, L., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000885

Effect of transcranial direct current stimulation combined ... tDCS, in conjunction with SLT, demonstrates potential enhancement in language recovery on post-ischemic stroke aphasia. It may improve speech content, naming ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6319389/

Transcranial direct current stimulation to treat aphasia A number of studies have suggested that active transcranial direct current stimulation (A-tDCS) may improve treatment outcomes when coupled with behavioral ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2024_AJSLP-23-00312

Effectiveness of Transcranial Direct Current Stimulation as ... Transcranial direct current stimulation (tDCS) is a neuromodulation tool to amplify neural excitability and enhance outcomes associated with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04963803

Improving Aphasia Using Electrical Brain Stimulation This research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-020-00708-z

Transcranial direct current stimulation (tDCS) for improving ... tDCS is an emerging approach for improving aphasia after stroke. However, it remains unclear what type of tDCS stimulation is most effective.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10783273/

The effectiveness and safety of noninvasive brain stimulation ... The NIBS technique combined with speech training can effectively improve the recovery of language function in PSA patients with minimal adverse effects.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4964590/

Transcranial Direct Current Stimulation in Post Stroke Aphasia ... tDCS is a safe, non-invasive, non-painful electrical stimulation of the brain which modulates cortical excitability by application of weak electrical currents.

8. mdpi.com mdpi.com/2076-3425/14/7/714

Behavioral, Functional Imaging, and Neurophysiological ... Recent studies suggest that combining transcranial direct current stimulation (tDCS) with SLT may improve language performance in persons with aphasia. However, ...