Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

NCT05364853 | Withdrawn

• 1 other identifier: 65669
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Keywords

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

In-Person Testing

OTHER

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

Behavioral: In-Person Testing

Remote Testing

OTHER

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

Behavioral: Remote Testing

Interventions

In-Person Testing BEHAVIORAL

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.

In-Person Testing

Remote Testing BEHAVIORAL

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.

Remote Testing

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kimford J Meador, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 6, 2022
• Study Start: April 1, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08