Maternal Outcomes and Neurodevelopmental Effects of Antiseizure Medications (MONEAM) - UG3 Phase

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05364853

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
Epilepsy	Behavioral: In-Person Testing Behavioral: Remote Testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Maternal Outcomes and Neurodevelopmental Effects of Antiseizure Medications (MONEAM) - UG3 Phase

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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

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

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.

Other: Remote Testing

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

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Kimford J Meador, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kimford Jay Meador, Professor of Neurology, Stanford University

ClinicalTrials.gov Identifier:

NCT05364853

Other Study ID Numbers:

65669

First Posted:

May 6, 2022

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kimford Jay Meador, Professor of Neurology, Stanford University

Epilepsy

Additional relevant MeSH terms:

Epilepsy

Study Results

No Results Posted as of May 6, 2022