Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Study Overview
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Brief Summary
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To compare in-person to remote video assessments in children to determine the reliability of remote evaluations for future neuropsychological assessments and set a precedent for future investigations.

Official Title
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Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: In-Person Testing
* Behavioral: Remote Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents able to provide informed consent for themselves and their child Access to computer and reliable internet connection for remote testing Child of women with epilepsy who was taking antiseizure medications during the pregnancy of the child being enrolled into the current study Child between the ages of 24 months and 30 months of age Primary language is English Exclusion Criteria: Child unable to complete the cognitive assessment (e.g., expected IQ<70) Child with a major medical condition (e.g., epilepsy, diabetes, heart disease, active cancer) Child who use centrally active medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: In-Person Testing<br>In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) in-person. | Behavioral: In-Person Testing<br>* Participants will be randomly assigned to have either in-person testing of the DAYC-2 conducted. They will then cross over into the other testing condition approximately 3 weeks after their first assessment.<br>|
| Other: Remote Testing<br>In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) remotely over video/telehealth. | Behavioral: Remote Testing<br>* Participants will be randomly assigned to have either remote testing of the DAYC-2 conducted. They will then cross over into the other testing condition approximately 3 weeks after their first assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental Assessment of Young Children-2nd edition (DAYC-2) Standard Scores of the Communication Domain as a Measure of Direct Comparison of the 2 Testing Conditions. | Standardized Scores of DAYC-2 Communication Domain at end of each period for each intervention (i.e., in-person testing and remote testing). The standard score indicates the deviation away from a reference population. A standard score of 100 is equal to the mean. Numbers less than 100 indicate poor cognitive performance compared to the mean and numbers greater than 100 represent higher cognitive performance compared to the mean. | Change from the first, baseline assessment to the second assessment, 21 days later. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy