Back to resultsNeurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
Primary Purpose
Epilepsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
In-Person Testing
Remote Testing
Sponsored by
About this trial
This is an interventional other trial for Epilepsy focused on measuring Epilepsy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
In-Person Testing
Remote Testing
Arm Description
In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) in-person.
In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) remotely over video/telehealth.
Outcomes
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05364853
Brief Title
Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
Official Title
Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2024 (Anticipated)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-Person Testing
Arm Type
Other
Arm Description
In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) in-person.
Arm Title
Remote Testing
Arm Type
Other
Arm Description
In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) remotely over video/telehealth.
Intervention Type
Behavioral
Intervention Name(s)
In-Person Testing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Remote Testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Change from the first, baseline assessment to the second assessment, 21 days later.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Seliger, MA
Phone
650-460-9260
Email
jseliger@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimford J Meador, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
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