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

Trial Summary

What is the purpose of this trial?

Language is a signature human cognitive skill, but the precise computations that support language understanding remain unknown. This study aims to combine high-quality human neural data obtained through intracranial recordings with advances in computational modeling of human cognition to shed light on the construction and understanding of speech.

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 data supports the effectiveness of the treatment Behavioral tasks during intracranial monitoring for language disorders?

Research shows that using advanced language mapping techniques, like computerized platforms during brain surgery, can improve the detection and understanding of language deficits. This suggests that similar behavioral tasks during intracranial monitoring could be effective in identifying and managing language disorders. ^{1 2 3 4 5}

Is intracranial monitoring for language disorders safe for humans?

The research does not provide specific safety data for intracranial monitoring tasks for language disorders, but a related study on transcranial direct current stimulation (tDCS) for language treatment in stroke survivors reported no serious adverse events, suggesting that similar non-invasive brain monitoring techniques may be safe. ^{1 2 6 7 8}

How does this treatment for language disorders differ from other treatments?

This treatment uses a novel computerized platform for language mapping during brain surgery, which is unique because it allows for more precise and flexible assessment of language function compared to traditional methods. It integrates with preoperative imaging and intraoperative testing to better identify and characterize language deficits, making it particularly useful during awake brain surgeries. ^{1 3 4 9 10}

Eligibility Criteria

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

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

The ability to comply with test directions and provide informed consent

I am between 18 and 85 years old.

Exclusion Criteria

I understand and can follow the study's requirements.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

A novel tablet computer platform for advanced language mapping during awake craniotomy procedures. [2022]

2. Switzerland 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. [2021]

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

Three- and four-dimensional mapping of speech and language in patients with epilepsy. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

[A Trial of Unified Management of Language Tasks Using a Tablet Device for Language Area Mapping]. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Localization patterns of speech and language errors during awake brain surgery: a systematic review. [2023]

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

Combined analysis of language tasks in fMRI improves assessment of hemispheric dominance for language functions in individual subjects. [2006]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Role of the lateral prefrontal cortex in speech monitoring. [2021]

8. United States 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. [2019]

9. United States 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. [2022]

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

Comparative localization of auditory comprehension by using functional magnetic resonance imaging and cortical stimulation. [2007]