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Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05364853
Enrollment
0
Registered
2022-05-06
Start date
2024-04-01
Completion date
2026-09-01
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy

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.

Interventions

BEHAVIORALIn-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.

BEHAVIORALRemote 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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026