Pediatric Language and Memory Mapping i… | Clinical Trial

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: MEG Acquisition

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.

Primary outcomes

Completed MEG

Time frame: only one measurement in one visit

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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: May 17, 2021
Registry last updated: Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed