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This is a pilot research study where language and working memory tasks will be used to study brain activities from children with epilepsy. Specifically for language assessment, a well-known MEG language protocol will be used and novel signal processing techniques will be applied. A widely utilized paradigm will be used to study memory function and adapt signal-processing techniques from previous literature for the processing and analysis of MEG signals collected during memory task. No treatment/intervention will be performed or evaluated in this pilot research study.
This is a pilot research study where language and working memory tasks will be used to study brain activities from children with epilepsy. Specifically for language assessment, a well-known MEG language protocol will be used and novel signal processing techniques will be applied. A widely utilized paradigm will be used to study memory function and adapt signal-processing techniques from previous literature for the processing and analysis of MEG signals collected during memory task. No treatment/intervention will be performed or evaluated in this pilot research study.
A MEG scan will be performed and data will be collected from ten pediatric subjects with drug-resistant focal epilepsy under evaluation for resective surgery. If a MRI scan is available from medical records and images have the appropriate characteristics for MEG (see more specifications at MRI section) analysis, MRI will be used for MEG source reconstruction. If MRI is not available, one scan will be performed. MRI is necessary to obtain brain anatomy for high quality MEG source reconstruction.
Quantitative parameters will be extracted from MEG data for evaluating language and memory functions. This is a pilot research study where we will test the feasibility of the recording of both standard language and well-known memory task in patients with epilepsy. This research is important to investigate, by a non-invasive means, possible patterns of language and memory organization that may in future guide surgery and limit potential loss of these functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Subjects | MEG baseline session Receptive Language Task Memory Task |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline MEG Test | Diagnostic Test | Each subject will have one MEG session with the recordings of baseline resting state, language and memory protocols. Subjects will have a break period between the language and memory tasks. MEG recordings will be acquired for approximately 35 minutes. The subject will be allowed to practice the language and memory tasks before the MEG recording to feel familiar with them. This practice phase will be a short version of the task administered by a computer and will take approximately 6 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Completed MEG | This is not a treatment/intervention study. Pilot study was to record brain activity utilizing a noninvasive MEG system during resting state, receptive language and working memory tasks. | only one measurement in one visit |
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Inclusion Criteria:
Exclusion Criteria:
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A total of fifteen (15) pediatric patients with drug-resistant focal epilepsy under evaluation for resective surgery will be recruited from the comprehensive epilepsy program of the Arkansas Children's Neuroscience Center. If the patient is eligible, they will be informed about this study during their routine clinic visits by their clinician, and asked if they are interested in participating. Those who express an interest will be provided with the informed consent form (ICF) approved by the UAMS Institutional Review Board (IRB).
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| Name | Affiliation | Role |
|---|---|---|
| Diana I Escalona-Vargas, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
Only one group: epilepsy group
10 pediatric patients with drug-resistant focal epilepsy were recruited from the comprehensive epilepsy program of the Arkansas Children's Neuroscience Center
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | only one group: epilepsy group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
8-21 years of age
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects. This is Not a Treatment/Intervention Study. | This is not a treatment/intervention study. Thus, we don't have comparison groups. Participants were not assigned into Participant Flow or intervention strategy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completed MEG | This is not a treatment/intervention study. Pilot study was to record brain activity utilizing a noninvasive MEG system during resting state, receptive language and working memory tasks. | We were able to record brain activity utilizing a noninvasive MEG system during resting state, receptive language and working memory tasks in 10 children with epilepsy. 1 MEG per subject enrolled | Posted | Number | participants | only one measurement in one visit |
|
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30 days
The definition of Adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | only one group: epilepsy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences (UAMS) | University of Arkansas for Medical Sciences (UAMS) | 501-526-6876 | ORRAClinicalTrials-govadmin@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2021 | Jul 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Receptive Language Task | Behavioral | The subject will perform a practice session where they will be instructed to "try to remember" a set of five audibly spoken English words, deemed targets (jump, little, please, drink, and good). Depending on the subject's overall verbal memory capacity, the target words will be presented once or twice during the practice phase. Subsequently, during the MEG recording, the five target words will repeat in a different random order, mixed with a different set of 40 distractors (non-repeating words) in each of three blocks of stimuli. The subject's task will be to listen to the words and lift their index finger of the dominant hand whenever they hear a repeated target word (one of the five). After the language task, the subject will be given a break. |
|
| Memory Task | Behavioral | The subject will be tasked with indicating whether the encoding stimulus matched the retrieval stimulus using two buttons; one for "congruent" and the other for "incongruent" response. Button type will be counterbalanced among subjects. The task will take around 16 minutes. The visual stimuli will be projected through an LCD projector onto a white screen located about 0.5 m in front of the subject and subtending 1.0-4.0 and 0.5 degrees of horizontal and vertical visual angle, respectively. A MEG compatible keyboard will be used to measure the subject's responses for "congruent" and "incongruent". The subject will practice the memory task before going to the MEG system using a computer from MEG laboratory. This practice phase will consist of a short version of the memory task with duration of approximately 4 minutes. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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