Intracranial Monitoring Tasks for Language Disorders

Overseen By Evelina Fedorenko, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the brain processes language by studying people with epilepsy who are already undergoing brain monitoring. Participants will perform simple behavioral tasks during intracranial monitoring while doctors observe brain activity to learn more about speech comprehension. The trial seeks individuals with epilepsy who require brain monitoring on the left side of the brain and can follow directions and provide consent.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on language processing in the brain.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that intracranial monitoring is safe for language disorder research?

Research has shown that performing behavioral tasks during brain monitoring is generally safe. Studies have found these activities to be non-invasive and free from serious side effects. Brain monitoring, a common procedure for diagnosing and treating epilepsy, further ensures safety. Overall, patients performing these tasks have not reported major problems, making the treatment manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using behavioral tasks during intracranial monitoring for language disorders because it offers a unique method to understand how the brain processes language in real-time. Unlike other treatments that rely on external observations or brain imaging, this approach directly monitors brain activity in patients with pharmaco-resistant epilepsy. This direct monitoring can provide more precise insights into the language processing areas of the brain, potentially leading to more effective, personalized therapies for language disorders.

What evidence suggests that these behavioral tasks during intracranial monitoring are effective for language disorders?

This trial involves epileptic participants undergoing intracranial monitoring to study language disorders. Although this trial does not include speech and language therapy, research has shown that such therapies can help people with chronic aphasia regain language skills. These therapies can enhance abilities like speaking, reading, and writing. For example, a Cochrane review found that individuals who received language therapy performed better than those who did not. Additionally, intensive language therapy over a few weeks has proven effective in clinical settings. Overall, strong evidence supports the effectiveness of these therapies in helping people with language disorders recover their language abilities. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with language disorders or epilepsy who are already scheduled for intracranial monitoring of the left cerebral hemisphere. Participants must be able to follow test instructions and give informed consent.

Inclusion Criteria

The ability to comply with test directions and provide informed consent

My medical team has recommended monitoring of my brain's left side for epilepsy.

Exclusion Criteria

I understand and can follow the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intracranial Monitoring

Neural responses to language stimuli are collected from epileptic patients undergoing intracranial monitoring

Up to 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral tasks during intracranial monitoring

Trial Overview The study investigates how the human brain processes language by having participants perform behavioral tasks during intracranial monitoring, aiming to combine neural data with computational models of cognition.

How Is the Trial Designed?

Group I: Epileptic participants undergoing intracranial monitoring Experimental Treatment 1 Intervention

Patients with pharmaco-resistant epilepsy undergoing intracranial monitoring involving the left cerebral hemisphere.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Published Research Related to This Trial

Event-related potential and eye tracking methods provide innovative ways to assess language processing in preverbal or minimally verbal individuals with neurodevelopmental disabilities, overcoming challenges posed by traditional behavioral assessments.

These methods allow for passive and minimally invasive evaluations, potentially serving as biomarkers for individual differences in language processing and indicators of treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychophysiological and Eye-Tracking Markers of Speech and Language Processing in Neurodevelopmental Disorders: New Options for Difficult-to-Test Populations. Key, AP., Venker, CE., Sandbank, MP.[2022]

In a study of 33 patients undergoing brain surgery, fMRI mapping of auditory comprehension showed consistent results with previous studies in healthy individuals, indicating its potential reliability for language localization.

Cortical stimulation confirmed fMRI findings in most patients, as it disrupted language functions in 12 out of 14 cases where fMRI showed activation, although discrepancies in the spatial extent of activation and disruption were noted, highlighting the need for careful interpretation in presurgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative localization of auditory comprehension by using functional magnetic resonance imaging and cortical stimulation. Schlosser, MJ., Luby, M., Spencer, DD., et al.[2007]

A new software tool using a tablet device was developed to assess patients' language abilities during awake craniotomy for brain tumor resection, allowing for real-time adjustments to the surgical plan based on the patient's neurological status.

In a case study of a 68-year-old female patient with worsening aphasia, the software enabled effective language task evaluation, leading to successful mapping of language areas in about 90 minutes, demonstrating its potential for enhancing surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Trial of Unified Management of Language Tasks Using a Tablet Device for Language Area Mapping]. Kawada, T., Kawasaki, A., Semizo, K., et al.[2019]

The study compared (15)O water PET scans with the intracarotid amobarbital procedure (IAP) for determining language lateralization in 12 patients with intractable epilepsy, showing that PET had a high positive predictive value (88-91%) for language dominance.

In one case, a patient with right-sided IAP language dominance but left-sided PET activation experienced significant dysphasia after left temporal lobectomy, highlighting the importance of accurate language lateralization assessment before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(15)O water positron emission tomography in language localization: a study comparing positron emission tomography visual and computerized region of interest analysis with the Wada test. Hunter, KE., Blaxton, TA., Bookheimer, SY., et al.[2019]

A new computerized platform for language mapping during awake craniotomy procedures significantly enhances the detection and characterization of language deficits compared to traditional methods, as demonstrated in four illustrative cases.

The platform showed excellent spatial agreement between intraoperative language mapping and preoperative fMRI results, confirming its efficacy in improving the accuracy of language assessments during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel tablet computer platform for advanced language mapping during awake craniotomy procedures. Morrison, MA., Tam, F., Garavaglia, MM., 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]

A systematic review of 102 studies on awake craniotomy with direct electrical stimulation (DES) revealed that 40% of speech and language errors occurred in subcortical areas, highlighting the importance of these regions in language function, which are often less studied during surgery.

The findings led to an updated Dutch Linguistic Intraoperative Protocol (DuLIP) model that provides better localization patterns for various language functions, potentially improving intraoperative language monitoring and postoperative language outcomes for glioma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localization patterns of speech and language errors during awake brain surgery: a systematic review. Collée, E., Vincent, A., Visch-Brink, E., et al.[2023]

The combined task analysis (CTA) method improves the detection of language-related brain activity in individuals and provides a reliable measure of language lateralization, particularly in right-handed males, where it confirms the expected left-hemisphere dominance for language.

CTA yields a more consistent language laterality index (LI) across different statistical thresholds compared to single-task analysis, making it a valuable tool for studying language functions in neuroimaging research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined analysis of language tasks in fMRI improves assessment of hemispheric dominance for language functions in individual subjects. Ramsey, NF., Sommer, IE., Rutten, GJ., et al.[2006]

This study involved 100 patients undergoing epilepsy surgery, using 3D and 4D mapping techniques to identify specific brain regions responsible for speech and language functions, revealing critical areas linked to various language impairments.

The findings suggest that the brain can rapidly switch activation between different regions during speech tasks, with older patients showing more left-dominant activation in language-related areas, which may help in predicting language function for presurgical evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three- and four-dimensional mapping of speech and language in patients with epilepsy. Nakai, Y., Jeong, JW., Brown, EC., et al.[2022]

The study found that patients with lateral prefrontal cortex (LPFC) damage performed worse in both linguistic and non-linguistic tasks, but their brain response (error negativity, Ne) only showed significant differences in the linguistic task (Picture Naming), suggesting that LPFC may not be essential for speech monitoring in simple tasks.

In contrast, the bilateral temporal cortex showed increased activity during speech monitoring, particularly when accessing lexical representations, indicating its critical role in real-time speech monitoring, especially in tasks requiring language processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the lateral prefrontal cortex in speech monitoring. Riès, SK., Xie, K., Haaland, KY., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8846581/

Aphasia recovery by language training using a brain ... In the chronic stage after stroke, it is effective compared with no treatment, but its effect size is small. We present a new language training ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/02687038.2023.2282659

The effects of cognitive-linguistic interventions to treat ... The Cochrane review found aphasia intervention can improve functional communication outcomes, reading, writing and expressive language compared to no ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01540383

Effectiveness of Intensive Aphasia Therapy Under Routine ... The purpose of this study is to examine whether 3 weeks of intensive language therapy provided in clinical in- and outpatient settings is effective in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10205105/

Predicting Outcomes of Language Rehabilitation Behavioral speech and language therapy (SLT) has eloquently been shown to be an effective approach to restoring language function in chronic aphasia (≥ 6 months ...

5. pubs.asha.org pubs.asha.org/doi/10.1044/2025_PERSP-24-00260

The Efficacy and Utility of Constant Therapy in Poststroke ... Scientific studies have demonstrated the effectiveness of CT in improving language outcomes, particularly in individuals with chronic poststroke ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4672964/

Performing Behavioral Tasks in Subjects with Intracranial ... Here we present a method for recording brain activity from intracranial implants as subjects perform a behavioral task designed to assess decision-making and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6094950/

Cognitive and behavioral interventions in epilepsy - PMC Cognitive and behavioral treatments for epilepsy offer several advantages, as they are relatively low cost, are noninvasive, lack serious side effects, and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05283265

Neurophysiological Mechanisms of Language ... The investigators will examine the effect of this stimulation on the subjects comprehension of the sentences measured by their behavior, and on the ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1059131125001700

Monitoring cognition in people with epilepsy and ... Monitoring cognition is essential in patients with epilepsy and intellectual disability (ID) to assess the course of the disease and its treatment.

10. nature.com nature.com/articles/s41597-021-01099-z

Intracranial electrophysiological recordings from the ... Intracranial EEG (iEEG) monitoring is a standard diagnostic procedure used to localize and treat sources of epileptogenic activities in patients ...