Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Not Applicable

Withdrawn

• Conditions: Epilepsy
• Interventions: Behavioral: In-Person Testing; Behavioral: Remote Testing

• Registration Number: NCT05364853
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-06
• Study Start: 2024-04-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2026-03-31
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Parents able to provide informed consent for themselves and their child
2. Access to computer and reliable internet connection for remote testing
3. Child of women with epilepsy who was taking antiseizure medications during the pregnancy of the child being enrolled into the current study
4. Child between the ages of 24 months and 30 months of age
5. Primary language is English

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Exclusion Criteria

1. Child unable to complete the cognitive assessment (e.g., expected IQ<70)
2. Child with a major medical condition (e.g., epilepsy, diabetes, heart disease, active cancer)
3. Child who use centrally active medications

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
In-Person Testing	In-Person Testing	In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) in-person.
Remote Testing	Remote Testing	In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) remotely over video/telehealth.

Primary Outcome Measures

Name	Time	Method
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.	Change from the first, baseline assessment to the second assessment, 21 days later.	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.