Cognitive Task Analysis for Epilepsy and Brain Cancer

Overseen By Eliana M Klier

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Gross structural abnormalities, impaired cognition, others

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

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand brain function in individuals with epilepsy or brain tumors by comparing their brain activity to those without these conditions. Researchers will use fMRI (a type of brain scan) and other techniques to identify key brain areas involved in tasks like language and movement. The study will map brain regions crucial for these functions, enhancing understanding of their interactions. Language-based tasks will assess these functions. This trial may suit individuals with epilepsy or brain tumors who are undergoing specific brain mapping procedures and are proficient in English. As an unphased study, it offers participants the chance to contribute to foundational research that could improve future treatments and interventions.

Will I have to stop taking my current medications?

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

What prior data suggests that these language-based tasks are safe for participants?

Research shows that tasks involving language, used in brain studies, are generally safe for participants. For example, a technique called ECoG, which records brain activity, helps map language areas in the brain and reduces the risk of seizures during surgery. This method is accurate and does not cause harm.

In other studies, advanced imaging performed before surgery has helped predict how language skills might be affected. This allows doctors to plan surgeries better, lowering the chance of language problems afterward. Some studies indicate that mild language issues can occur, but they are usually not serious.

Overall, evidence suggests that language-based tasks in these studies are well-tolerated and have a good safety record. While minor language effects might occur, the risk of serious problems is low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using language-based tasks for treating epilepsy and brain cancer because this approach is non-invasive and focuses on brain function during specific cognitive activities. Unlike traditional treatments like medication or surgery, which can have significant side effects and risks, language-based tasks aim to enhance brain activity and potentially improve cognitive functions without surgical intervention. This method could lead to more personalized treatment plans by identifying how different parts of the brain respond to language tasks, ultimately helping tailor more effective strategies for managing these complex conditions.

What evidence suggests that language-based tasks are effective for studying brain function in epilepsy and brain cancer?

This trial will involve neural recordings and stimulation during language tasks to study brain function in people with epilepsy and brain tumors. Research has shown that language-based tasks can reveal how the brain functions in these conditions. These tasks often use tools like Direct Electrical Stimulation to identify important language areas in the brain. One study found that these tasks reliably activate key language areas, which is crucial for understanding and protecting brain function. Another study discovered that tumors can affect the efficiency of language networks, emphasizing the need for accurate mapping. These findings support the idea that language tasks effectively highlight essential brain areas involved in language processing. ^{1 5 6 7 8}

Who Is on the Research Team?

Nitin Tandon, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for English-speaking patients with medically refractory epilepsy or brain tumors near crucial brain regions. They may have electrodes implanted to locate seizure sites and map critical areas, or they might undergo intra-op mapping, a Wada test, or an awake craniotomy.

Inclusion Criteria

Proficiency in English

I have a brain condition and may need or had surgery involving brain function tests.

I have epilepsy that doesn't respond to medication and will have or had surgery to place electrodes in my brain.

Exclusion Criteria

Patients with claustrophobia who cannot undergo an MRI scan without sedation

Cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices

I have significant brain abnormalities that could affect critical areas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neural Recording and Stimulation

Participants undergo neural recordings and stimulation during language tasks using fMRI and cortical stimulation mapping

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after neural recordings and stimulation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Language-based tasks

Trial Overview The study aims to compare normal brain function using fMRI in healthy subjects versus those with epilepsy or brain tumors. It involves language-based tasks and will use data from intracranial recordings to analyze information flow between brain areas.

How Is the Trial Designed?

Group I: Neural recordings and stimulation during language tasks Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Approximately 31% of cancer patients undergoing chemotherapy reported significant cognitive decline, indicating that cognitive impairment is a common issue during treatment.

Risk factors for cognitive decline included increased fatigue and undergoing two or more cycles of chemotherapy, suggesting that monitoring cognitive function early in treatment could be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy-associated cognitive impairments in Korean cancer patients: Risk factors and functional outcome. Kim, HJ., Barsevick, AM., Chan, A., et al.[2019]

The GE2REC protocol effectively maps language and memory networks in patients with left temporal lobe epilepsy (LTLE), demonstrating significant reorganization in brain activity compared to healthy controls, based on a study involving 18 LTLE patients.

This protocol is beneficial for clinical practice as it is quick to perform, assesses cognitive functions at an individual level, and provides insights into the interaction between language and memory, which can aid in neurosurgical planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping of Language-and-Memory Networks in Patients With Temporal Lobe Epilepsy by Using the GE2REC Protocol. Banjac, S., Roger, E., Cousin, E., et al.[2022]

In a large study of 581 breast cancer patients and 364 age-matched controls, patients reported significantly greater cognitive difficulties after chemotherapy, with 45.2% experiencing a clinically significant decline in cognitive function compared to only 10.4% of controls.

The study found that increased baseline anxiety and depression were linked to lower cognitive function scores, while treatment type (chemotherapy regimen, hormone, or radiation therapy) did not significantly affect cognitive outcomes post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. Janelsins, MC., Heckler, CE., Peppone, LJ., et al.[2022]

In a study of 68 brain tumor patients, 58.8% showed cognitive impairment on at least one neuropsychological test, highlighting the prevalence of cognitive challenges in this population.

A brief battery of four specific cognitive tests (Figure Copy, Coding, List Recognition, and Story Recall) effectively identified 90% of the impaired patients, suggesting these tasks are crucial for assessing cognitive changes in clinical trials for brain tumor therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing neuropsychological tasks to optimize brief cognitive batteries for brain tumor clinical trials. Lageman, SK., Cerhan, JH., Locke, DE., et al.[2022]

In a study of 45 patients with epilepsy and a left hemisphere seizure focus, researchers found that language processing regions can reorganize, with some patients showing increased activation in the left temporal area while others recruited right hemisphere regions.

The study identified four sub-groups of patients based on their brain activation patterns, suggesting that inter-hemispheric reorganization is constrained and that some patients exhibit limited intra-hemispheric reorganization, which could have implications for understanding language processing in both healthy and disordered brains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Limitations to plasticity of language network reorganization in localization related epilepsy. Mbwana, J., Berl, MM., Ritzl, EK., et al.[2022]

Adjuvant chemotherapy for breast cancer may lead to cognitive deficits that can significantly affect patients' quality of life, with ongoing studies aiming to better quantify these effects and identify susceptible subgroups.

There is a growing interest in understanding the cognitive impact of estrogen deprivation from aromatase inhibitors and exploring supportive measures to mitigate cognitive effects associated with chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of adjuvant therapy for breast cancer on cognitive function: current evidence and directions for research. Rugo, HS., Ahles, T.[2019]

In a study of 10 glioma patients compared to 60 healthy controls, patients generally performed well on most multimodal processing tasks but struggled specifically with productive picture-naming, receptive verbal judgment, and visual/graphic tasks.

The difficulties experienced by glioma patients did not correlate with the location of their tumors or tumor type, suggesting that individual variability plays a significant role in how gliomas affect cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strengths and weaknesses of multimodal processing in a group of adults with gliomas. Plaza, M., Capelle, L., Maigret, G., et al.[2013]

In a study involving four women with breast cancer and 18 healthy controls, no significant cognitive or language performance differences were found between the groups during the early stages of tamoxifen treatment, although women with breast cancer generally performed worse than controls.

Some women with breast cancer did show cognitive and language declines during the initial treatment with tamoxifen, indicating that monitoring these changes is important and may lead to the need for future language interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tamoxifen Effects on Cognition and Language in Women with Breast Cancer. Sharma, S., Wright, HH.[2023]

A study of 23 patients with drug-resistant epilepsy found that interictal discharges (IEDs) significantly contribute to word-finding difficulties, particularly through impairments in long-term lexicosemantic memory and phonological working memory.

Medial temporal lobe IEDs were especially impactful, suggesting that targeting these discharges with new treatments like pharmacological interventions or neurostimulation could help improve memory and language issues in epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interictal epileptiform discharges contribute to word-finding difficulty in epilepsy through multiple cognitive mechanisms. Silva, AB., Leonard, MK., Oganian, Y., et al.[2023]

Using a panel of fMRI tasks targeting different aspects of language processing in 26 epilepsy patients improved the accuracy of determining language dominance compared to single-task paradigms.

The study found excellent agreement between fMRI results and the intracarotid amobarbital test (IAT) in 21 out of 25 patients, demonstrating that a multi-task approach enhances interrater reliability and reduces nondiagnostic findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

fMRI language task panel improves determination of language dominance. Gaillard, WD., Balsamo, L., Xu, B., et al.[2023]

A study involving 487 epilepsy cases highlighted that common methods for assessing cognitive deficits often face issues like poor test selection and sampling problems, which can affect the results.

Even when using advanced multivariate techniques to analyze seizure history variables, the relationships with cognitive functioning remained limited, indicating that many factors influencing cognitive abilities in epilepsy are still not well understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interictal cognitive aspects of epilepsy. Dodrill, CB.[2007]

In a study of 136 patients with severe intractable epilepsy, cognitive decline was found to be significant across various functions, with the frequency of generalized tonic-clonic seizures being the strongest predictor of this decline.

Good seizure control, even after long periods of intractability, was associated with better cognitive outcomes, suggesting that managing seizures can positively impact cognitive health over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive decline in severe intractable epilepsy. Thompson, PJ., Duncan, JS.[2022]

Cognitive impairment in frontal lobe epilepsy (FLE) is linked to reduced activation in attentional and executive brain systems, as well as insufficient deactivation of the default mode network, indicating a disorganized response during cognitive tasks.

While there are similarities in cognitive impairment patterns between frontal lobe epilepsy (FLE) and temporal lobe epilepsy (TLE), specific differences exist, such as more pronounced default mode dysfunction in FLE and greater issues with language processing in TLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disorganization of language and working memory systems in frontal versus temporal lobe epilepsy. Caciagli, L., Paquola, C., He, X., et al.[2023]

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