EpilepsyNCT04888637
Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography
An observational study of Epilepsy, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Baseline MEG Test, Receptive Language Task and Memory Task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 22 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Baseline MEG Test, Receptive Language Task, Memory Task
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline MEG TestDiagnostic test
Also called MEG Acquisition
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.
Receptive Language TaskBehavioural
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 TaskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | MEG baseline session Receptive Language Task Memory Task Receives: Diagnostic Test: Baseline MEG Test; Behavioral: Receptive Language Task; Behavioral: Memory Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: only one measurement in one visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start14 Jul 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana I Escalona-Vargas, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888637
- Sponsor's protocol ID
- 261511
- Status last verified
- Mar 2024
- First submitted
- 11 May 2021
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Language and Memory Mapping in Refractory Epilepsy Using Magnetoencephalography
- ClinicalTrials.gov ID
- NCT04888637
- Acronym / sponsor ID
- 261511
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | – | Diagnostic Test: Baseline MEG Test, Behavioral: Receptive Language Task, Behavioral: Memory TaskMEG baseline session Receptive Language Task Memory Task |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline MEG TestAlso: MEG AcquisitionEach 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. | Diagnostic test | All Subjects |
| Receptive Language TaskThe 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. | Behavioural | All Subjects |
| Memory TaskThe 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. | Behavioural | All Subjects |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana I Escalona-Vargas, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completed MEG (time frame: only one measurement in one visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.