Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography

NCT04888637 | Completed Results

• 1 other identifier: 261511
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All Subjects

MEG baseline session Receptive Language Task Memory Task

Diagnostic Test: Baseline MEG Test; Behavioral: Receptive Language Task; Behavioral: Memory Task

Interventions

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.

Also known as: MEG Acquisition

All Subjects

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.

All Subjects

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.

All Subjects

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: University of Arkansas for Medical Sciences (UAMS)
• Organization: University of Arkansas for Medical Sciences (UAMS)

ORRAClinicalTrials-govadmin@uams.edu

501-526-6876

Study Officials

• Diana I Escalona-Vargas, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: July 14, 2021
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2024-03

Locations

US (1)