Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Epilepsy Clinical Trial

Official title:

Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05364853
• Other study ID #: 65669
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: July 2023
• Source: Stanford University
• Contact: Jordan Seliger, MA
• Phone: 650-460-9260
• Email: jseliger[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: September 1, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.