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Clinical Trials/NCT04888637
NCT04888637
Completed
Not Applicable

Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography

University of Arkansas1 site in 1 country10 target enrollmentJuly 14, 2021
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
University of Arkansas
Enrollment
10
Locations
1
Primary Endpoint
Completed MEG
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 14, 2021
End Date
July 22, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

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.

Study Sites (1)

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