Neurodevelopmental Effects of Antiseizure Medications (NEAM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-09-01

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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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In-Person Testing

In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) in-person.

Group Type OTHER

In-Person Testing

Intervention Type BEHAVIORAL

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.

Remote Testing

In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) remotely over video/telehealth.

Group Type OTHER

Remote Testing

Intervention Type BEHAVIORAL

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.

Interventions

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In-Person Testing

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.

Intervention Type BEHAVIORAL

Remote Testing

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No