Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase

August 15, 2024 updated by: Kimford Jay Meador, Stanford University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Change from the first, baseline assessment to the second assessment, 21 days later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Kimford J Meador, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 15, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on In-Person Testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe