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NCT05364853 | Not yet recruiting | Epilepsy


Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
Sponsor:

Stanford University

Information provided by (Responsible Party):

Kimford Jay Meador

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.

Condition or disease

Epilepsy

Intervention/treatment

In-Person Testing

Remote Testing

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 35 participants
Masking : None (Open Label)
Primary Purpose : Other
Official Title : Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
Actual Study Start Date : April 1, 2024
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : September 1, 2026
Arm Intervention/treatment

Other: In-Person Testing

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

Behavioral: In-Person Testing

Other: Remote Testing

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

Behavioral: Remote Testing

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Parents able to provide informed consent for themselves and their child
  • Access to computer and reliable internet connection for remote testing
  • Child of women with epilepsy who was taking antiseizure medications during the pregnancy of the child being enrolled into the current study
  • Child between the ages of 24 months and 30 months of age
  • Primary language is English
Exclusion Criteria
  • Child unable to complete the cognitive assessment (e.g., expected IQ<70)
  • Child with a major medical condition (e.g., epilepsy, diabetes, heart disease, active cancer)
  • Child who use centrally active medications

Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

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Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

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