Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

Stanford University

Status: Withdrawn

Conditions: Epilepsy

Treatments: Behavioral: In-Person Testing; Behavioral: Remote Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05364853

65669

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

In-Person Testing

Other group

Description:

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

Treatment:

Behavioral: In-Person Testing

Remote Testing

Other group

Description:

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

Treatment:

Behavioral: Remote Testing