Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography

Epilepsy Clinical Trial

Official title:

Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888637
• Other study ID #: 261511
• Status: Completed
• Start date: July 14, 2021
• Est. completion date: July 22, 2022

Study information

• Verified date: October 2022
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 22, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Diagnostic Test:
• Baseline 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.

Behavioral:
• Receptive Language Task
The subject will perform a practice session where they will be instructed to "try to remember" a set of ?ve 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 ?ve 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
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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemispheric dominance	Estimation of hemispheric dominance for language and memory will be calculated as the degree of activation of each hemisphere during performance of the task. We will derive an estimate of hemispheric dominance by calculating the difference in activation levels between the hemispheres.	from Baseline to end of study, up to one month