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Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography

Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04888637
Enrollment
10
Registered
2021-05-17
Start date
2021-07-14
Completion date
2022-07-22
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTBaseline MEG 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.

BEHAVIORALReceptive Language Task

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.

BEHAVIORALMemory Task

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.

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

* 8 to 21 years old * Drug-resistant focal epilepsy * Enrolled in the Arkansas Children's Neuroscience Center Comprehensive Epilepsy Program * Under evaluation for resective surgery * English speakers. This is not a treatment/intervention study.

Exclusion criteria

* Previous resective surgery for epilepsy * Presence of progressive neurodegenerative disorders * Presence of significant magnetic artifacts; electronic, magnetic or metallic implants (e.g. pins, screws, shrapnel remains, surgical clips, artificial heart valves, cochlear implants, vascular stents pacemakers); or permanent make-up or tattoos made with metallic dyes * Presence of seizures within 24 hours of the MEG * Use of sedation during the MEG acquisition * Inability to be in a seated or supine position during the tasks * Major medical disorders (e.g. HIV, cancer) * Significant visual or auditory disabilities * Physical disabilities that interfere with accomplishment of study tasks (when applicable) * Claustrophobia, or fear of cramped or confined spaces * Pregnancy or suspected pregnancy * Any condition that the investigator feels might put the patient at risk

Design outcomes

Primary

MeasureTime frameDescription
Completed MEGonly one measurement in one visitThis 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.

Countries

United States

Participant flow

Recruitment details

10 pediatric patients with drug-resistant focal epilepsy were recruited from the comprehensive epilepsy program of the Arkansas Children's Neuroscience Center

Pre-assignment details

Only one group: epilepsy group

Participants by arm

ArmCount
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.
10
Total10

Baseline characteristics

CharacteristicAll Subjects. This is Not a Treatment/Intervention Study.
Age, Categorical
<=18 years
10 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

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.

Time frame: only one measurement in one visit

Population: 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

ArmMeasureValue (NUMBER)
All SubjectsCompleted MEG1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026