Modification of Epilepsy Screen Questionnaire and Treatment Feasibility Evaluation
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
Atypical presentations in epilepsy may include confusion status, acute maniac or delirious condition, loss of cognitive ability such as speech, interaction skills, or other praxis. Current diagnosis of epilepsy did not address on definition of seizure. The new insights of seizure semiology and their treatment response, suggest the screen tool and diagnostic criteria of epilepsy can be revised. In this study, we have two aims. The first aim is to develop a screening questionnaire by adding new semiology of epilepsy, including abnormality in psychiatry, cognition, and sleep, and to test its accuracy. The second aim is to evaluate the benefits in cognition of anti-epileptic drug intervention in participants with positive screening results.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJune 25, 2021
June 1, 2021
2 years
June 15, 2021
June 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Mini-Mental State Examination
The Mini-Mental State Examination is a common analysis of cognitive function, with a score range from 0 to 30, and higher score indicates a better performance of cognition. We hypothesized that differences after ASM intervention will have a difference score of 4 in comparison to the observational group.
12 weeks
Secondary Outcomes (2)
Pattern changes in electroencephalography
12 weeks
Neuropsychiatric Inventory Questionnaire
12 weeks
Study Arms (2)
Anti-seizure medication
EXPERIMENTALThe intervention group will receive anti-epileptic drug treatment according to the guideline of American Epilepsy Society 15 for 12 weeks. The recommended regimens include zonisamide, lamotrigine, or levetiracetam at the minimal therapeutic doses (zonisamide 100mg twice daily, levetiracetam 500mg twice daily, lamotrigine 50mg twice daily), and the choices depend on tolerability of the participants and contraindications (allergy to any drugs, or allergy to sulphonamides in zonisamide users). The participants will be followed every 4 weeks.
Observation
NO INTERVENTIONThe participants will be followed every 4 weeks without anti-seizure medication.
Interventions
Only one ASM will be used. The drug choice depends on patients tolerance and basic condition. Twice daily
Only one ASM will be used. The drug choice depends on patients tolerance and basic condition. Twice daily
Only one ASM will be used. The drug choice depends on patients tolerance and basic condition. Twice daily
Eligibility Criteria
You may qualify if:
- \. Age equal or more than 20-year-old 2a. Patients already diagnosed of epilepsy 2b. Non-epileptic patients from outpatient and inpatient settings of National Taiwan University Hospital (NTUH) and National Taiwan University Hospital Yunlin Branch (NTUHYL) 2c. Community health people
You may not qualify if:
- Participants with cognitive decline (Clinical dementia rating \> 1) and could not answer the questionnaire reliably. However, participants will be recruited if their caregivers are fully aware of their recent condition and will help to complete the questionnaire.
- Pregnancy or breast-feeding
- Having adverse effect to all the anti-epileptic drug used in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kai-Chieh Chang, M.D.
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2021
First Posted
June 25, 2021
Study Start
July 1, 2021
Primary Completion
June 30, 2023
Study Completion
June 30, 2025
Last Updated
June 25, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share