Clinical trial NCT04888637: Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography
Official title: Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completed MEG
timeFrame: only one measurement in one visit
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Diana I Escalona-Vargas, PhD
role: PRINCIPAL_INVESTIGATOR
References: