EpilepsyNCT05364853
Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
A study testing In-Person Testing and Remote Testing in people with Epilepsy, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- In-Person Testing and Remote Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Being tested
- In-Person Testing, Remote Testing
- Keywords
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person TestingBehavioural
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.
Remote TestingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Testing | Other | In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) in-person. Receives: Behavioral: In-Person Testing |
| Remote Testing | Other | In this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) remotely over video/telehealth. Receives: Behavioral: Remote Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from the first, baseline assessment to the second assessment, 21 days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 Apr 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Study did not receive funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimford Jay Meador, Stanford University
- Investigators
- Kimford J Meador, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364853
- Sponsor's protocol ID
- 65669
- Status last verified
- Aug 2024
- First submitted
- 21 Apr 2022
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Effects of Antiseizure Medications (NEAM) - UG3 Phase
- ClinicalTrials.gov ID
- NCT05364853
- Acronym / sponsor ID
- 65669
- Conditions
- Epilepsy
- Keywords
- Epilepsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not receive funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Testing | Other | Behavioral: In-Person TestingIn this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) in-person. |
| Remote Testing | Other | Behavioral: Remote TestingIn this arm, participants will undergo the neuropsychological assessment of interest (DAYC-2) remotely over video/telehealth. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person TestingParticipants 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. | Behavioural | In-Person Testing |
| Remote TestingParticipants 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. | Behavioural | Remote Testing |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimford J Meador, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing In-Person Testing and Remote Testing in people with Epilepsy, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.