Cognitive Task Analysis for Epilepsy and Brain Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center, Houston
Disqualifiers: Gross structural abnormalities, impaired cognition, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions "essential" for these processes, to compare the loci of "crucial" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas.
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 data supports the effectiveness of the treatment Language-based tasks for epilepsy and brain cancer?
The GE2REC protocol, which involves language and memory tasks, has been shown to map language and memory networks in patients with temporal lobe epilepsy, suggesting it could be useful in clinical practice for assessing cognitive functions. This protocol has been validated in healthy participants and shows potential for guiding neurosurgical planning and understanding brain reorganization in epilepsy patients.
12345Is cognitive task analysis safe for humans?
The research does not provide specific safety data for cognitive task analysis in humans, but it does suggest that cognitive tasks are commonly used in clinical trials for brain tumors and other conditions without reported safety concerns.
678910How does the Cognitive Task Analysis treatment for epilepsy and brain cancer differ from other treatments?
The Cognitive Task Analysis treatment is unique because it focuses on understanding and mapping cognitive functions like language and memory in patients with epilepsy and brain cancer. This approach helps in identifying how these functions are reorganized in the brain, which can guide personalized treatment plans and improve outcomes, unlike standard treatments that may not consider individual cognitive reorganization.
59111213Eligibility Criteria
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.
+1 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Neural recordings and stimulation during language tasksExperimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
fMRI language task panel improves determination of language dominance. [2023]fMRI language tasks reliably identify language areas in presurgical epilepsy patients, but activation using single paradigms may disagree with the intracarotid amobarbital test (IAT).
Interictal cognitive aspects of epilepsy. [2007]Common methodological problems in the assessment of interictal cognitive deficits in epilepsy include limitations in neuropsychological tests selected and subject sampling problems. Neuropsychological functioning is related to a series of seizure history variables with an emphasis on those seizure factors showing the closest relationships. However, even these relationships are limited in scope, and it has been noted that no study has used multivariate procedures to demonstrate maximal relationships with measures of mental abilities. This technique was applied to data on 487 cases, and slightly stronger relationships were produced. However, this still did not account for the vast majority of the variance in cognitive tests. Conclusions concerning neuropsychological functioning in epilepsy require careful attention to sampling problems and other factors, and seizure history variables have only limited relationships with cognitive functioning, even when they are combined in an optimal fashion.
Disorganization of language and working memory systems in frontal versus temporal lobe epilepsy. [2023]Cognitive impairment is a common comorbidity of epilepsy and adversely impacts people with both frontal lobe (FLE) and temporal lobe (TLE) epilepsy. While its neural substrates have been investigated extensively in TLE, functional imaging studies in FLE are scarce. In this study, we profiled the neural processes underlying cognitive impairment in FLE and directly compared FLE and TLE to establish commonalities and differences. We investigated 172 adult participants (56 with FLE, 64 with TLE and 52 controls) using neuropsychological tests and four functional MRI tasks probing expressive language (verbal fluency, verb generation) and working memory (verbal and visuo-spatial). Patient groups were comparable in disease duration and anti-seizure medication load. We devised a multiscale approach to map brain activation and deactivation during cognition and track reorganization in FLE and TLE. Voxel-based analyses were complemented with profiling of task effects across established motifs of functional brain organization: (i) canonical resting-state functional systems; and (ii) the principal functional connectivity gradient, which encodes a continuous transition of regional connectivity profiles, anchoring lower-level sensory and transmodal brain areas at the opposite ends of a spectrum. We show that cognitive impairment in FLE is associated with reduced activation across attentional and executive systems, as well as reduced deactivation of the default mode system, indicative of a large-scale disorganization of task-related recruitment. The imaging signatures of dysfunction in FLE are broadly similar to those in TLE, but some patterns are syndrome-specific: altered default-mode deactivation is more prominent in FLE, while impaired recruitment of posterior language areas during a task with semantic demands is more marked in TLE. Functional abnormalities in FLE and TLE appear overall modulated by disease load. On balance, our study elucidates neural processes underlying language and working memory impairment in FLE, identifies shared and syndrome-specific alterations in the two most common focal epilepsies and sheds light on system behaviour that may be amenable to future remediation strategies.
Cognitive decline in severe intractable epilepsy. [2022]To explore the relation between seizure-related variables and cognitive change in patients with severe intractable epilepsy.
Mapping of Language-and-Memory Networks in Patients With Temporal Lobe Epilepsy by Using the GE2REC Protocol. [2022]Preoperative mapping of language and declarative memory functions in temporal lobe epilepsy (TLE) patients is essential since they frequently encounter deterioration of these functions and show variable degrees of cerebral reorganization. Due to growing evidence on language and declarative memory interdependence at a neural and neuropsychological level, we propose the GE2REC protocol for interactive language-and-memory network (LMN) mapping. GE2REC consists of three inter-related tasks, sentence generation with implicit encoding (GE) and two recollection (2REC) memory tasks: recognition and recall. This protocol has previously been validated in healthy participants, and in this study, we showed that it also maps the LMN in the left TLE (N = 18). Compared to healthy controls (N = 19), left TLE (LTLE) showed widespread inter- and intra-hemispheric reorganization of the LMN through reduced activity of regions engaged in the integration and the coordination of this meta-network. We also illustrated how this protocol could be implemented in clinical practice individually by presenting two case studies of LTLE patients who underwent efficient surgery and became seizure-free but showed different cognitive outcomes. This protocol can be advantageous for clinical practice because it (a) is short and easy to perform; (b) allows brain mapping of essential cognitive functions, even at an individual level; (c) engages language-and-memory interaction allowing to evaluate the integrative processes within the LMN; (d) provides a more comprehensive assessment by including both verbal and visual modalities, as well as various language and memory processes. Based on the available postsurgical data, we presented preliminary results obtained with this protocol in LTLE patients that could potentially inform the clinical practice. This implies the necessity to further validate the potential of GE2REC for neurosurgical planning, along with two directions, guiding resection and describing LMN neuroplasticity at an individual level.
Tamoxifen Effects on Cognition and Language in Women with Breast Cancer. [2023]Cognitive changes following adjuvant treatment for breast cancer (BC) are well documented following chemotherapy. However, limited studies have examined cognitive and/or language functions in chemotherapy-naive women with BC taking tamoxifen (TAM). Using ambulatory cognitive assessment, we investigated the trajectory of cognitive and language changes during early period of adjuvant endocrine treatment (TAM) in women with BC at two time periods (pretreatment and 2 months after treatment began). Four women with BC and 18 cognitively healthy age-matched controls completed three cognitive tasks using smartphones, during a short time period (5 days) and repeated them at two time periods. To determine language ability, language samples were collected at two time periods, where the participants described two stories from two wordless picture books and samples were assessed using core lexicon analyses. Wilcoxon-signed rank tests were computed to identify differences in linguistic and cognitive performances of both the groups at two time periods. No significant within-group or between-group differences were seen on the cognitive and language tasks at the two time periods; however, women with BC performed more poorly compared to the control group. We did see decline in some women with BC and not in others, in cognition and language during initial course of TAM treatment. However, the approach we used to assess these changes is valuable and innovative. This approach will help refine current research paradigms for determining cognitive and linguistic changes and will help determine if women with BC might require language intervention in the future.
Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. [2022]Purpose Cancer-related cognitive impairment is an important problem for patients with breast cancer, yet its trajectory is not fully understood. Some previous cancer-related cognitive impairment research is limited by heterogeneous populations, small samples, lack of prechemotherapy and longitudinal assessments, use of normative data, and lack of generalizability. We addressed these limitations in a large prospective, longitudinal, nationwide study. Patients and Methods Patients with breast cancer from community oncology clinics and age-matched noncancer controls completed the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at prechemotherapy and postchemotherapy and at a 6-month follow-up as an a priori exploratory aim. Longitudinal models compared FACT-Cog scores between patients and controls at the three assessments and adjusted for age, education, race, menopausal status, and baseline reading ability, anxiety, and depressive symptoms. A minimal clinically important difference cutoff determined percentages of impairment over time. Results Of patients, 581 patients with breast cancer (mean age, 53 years; 48% anthracycline-based regimens) and 364 controls (mean age, 53 years) were assessed. Patients reported significantly greater cognitive difficulties on the FACT-Cog total score and four subscales from prechemotherapy to postchemotherapy compared with controls as well as from prechemotherapy to 6-month follow-up (all P
The impact of adjuvant therapy for breast cancer on cognitive function: current evidence and directions for research. [2019]Available evidence supports the hypothesis that adjuvant chemotherapy for breast cancer can produce cognitive deficits, and that these deficits may have a significant impact on patients' quality of life. Studies have generally compared the results of a variety of cognitive measures performed following treatment to standardized population-based norms or to cancer patients who received local therapy, rather than to the individual's baseline level of functioning. Several longitudinal studies are in progress or in the planning stages to better quantify and understand the incidence and impact of cognitive effects of adjuvant chemotherapy, and to identify possible susceptibility factors in subgroups. Although the neurocognitive changes appear to be subtle, there may be enough data to consider discussing the possibility of cognitive dysfunction as an adverse effect when assessing the risks and benefits of adjuvant chemotherapy. Likewise, as the aromatase inhibitors are increasingly given to larger numbers of women in the adjuvant setting, it will be important to understand the cognitive impact of estrogen deprivation. Finally, there is interest in examining supportive pharmacologic or behavioral measures that might prevent or decrease cognitive effects in this setting. Herein, the data on cognitive changes associated with chemotherapy for breast cancer, current and future research directions, as well as possible treatments are reviewed.
Comparing neuropsychological tasks to optimize brief cognitive batteries for brain tumor clinical trials. [2022]Neuropsychological tests are increasingly being used as outcome measures in clinical trials of brain tumor therapies. This study informs development of brief neurocognitive batteries for clinical trials by identifying cognitive tasks that detect effects on a group level in a mixed brain tumor population. This is a retrospective study of brain tumor patients who completed a standardized battery sampling multiple cognitive domains using twelve subtests with widely-used task formats (the Repeatable Battery for the Assessment of Neuropsychological Status). Sixty-eight patients with brain tumors were studied (60% high-grade glioma). Forty patients (58.8%) were impaired (>2 standard deviations below published means) on at least one subtest. A combination of four subtests (Figure Copy, Coding, List Recognition, and Story Recall) captured 90% of the impaired subgroup. These results suggest visuoconstruction, processing speed, and verbal memory measures may be the most important domains to assess when evaluating cognitive change in brain tumor clinical trials.
Chemotherapy-associated cognitive impairments in Korean cancer patients: Risk factors and functional outcome. [2019]To identify those experiencing significant self-reported cognitive decline over 2 time points during chemotherapy, examine the risk factors for cognitive decline, and examine differences between those with and without significant decline in functional limitations.
Limitations to plasticity of language network reorganization in localization related epilepsy. [2022]Neural networks for processing language often are reorganized in patients with epilepsy. However, the extent and location of within and between hemisphere re-organization are not established. We studied 45 patients, all with a left hemisphere seizure focus (mean age 22.8, seizure onset 13.3), and 19 normal controls (mean age 24.8) with an fMRI word definition language paradigm to assess the location of language processing regions. Individual patient SPM maps were compared to the normal group in a voxel-wise comparison; a voxel was considered to be significant if its z-value exceeded mid R:2mid R:. Subsequently, we used principal component analysis with hierarchical clustering of variance patterns from individual difference maps to identify four patient sub-groups. One did not differ from normal controls; one had increased left temporal activation on the margin of regions activated in controls; two others had recruitment in right inferior frontal gyrus, middle frontal gyrus and temporal cortex. Right hemisphere activation in these two groups occurred in homologues of left hemisphere regions that sustained task activation. Our study used novel data driven methods to find evidence for constraints on inter-hemispheric reorganization of language in recruitment of right homologues, and, in a subpopulation of patients, evidence for intra-hemispheric reorganization of language limited to the margins of typical left temporal regional activation. These methods may be applied to investigate both normal and pathological variance in other developmental disorders and cognitive domains.
Interictal epileptiform discharges contribute to word-finding difficulty in epilepsy through multiple cognitive mechanisms. [2023]Cognitive impairment often impacts quality of life in epilepsy even if seizures are controlled. Word-finding difficulty is particularly prevalent and often attributed to etiological (static, baseline) circuit alterations. We sought to determine whether interictal discharges convey significant superimposed contributions to word-finding difficulty in patients, and if so, through which cognitive mechanism(s).
Strengths and weaknesses of multimodal processing in a group of adults with gliomas. [2013]The present study aimed to analyze the multimodal skills that would be spared, altered, or impaired by gliomas that slowly infiltrate various and diversely localized areas in the cerebral hemispheres. Ten patients and 60 healthy controls were evaluated using four multimodal processing paradigms across 11 tasks. Our objectives were as follows: (a) to describe the strengths and weaknesses of the glioma patients' multimodal processing performance after accounting for task specificity and their individual performances compared to those of the control group; (b) to determine the correlation between lesion localization and impairments; and (c) to identify the tasks that were most sensitive to tumor infiltration and plasticity limits. Our results show that patients as a whole were efficient at most tasks; however, the patients exhibited difficulties in the productive picture-naming task, the receptive verbal judgment task, and the visual/graphic portion of the dual-attention task. The individual case reports show that the difficulties were distributed across the patients and did not correlate with lesion localization and tumor type.