Psychiatric Comorbidities in Children With Generalized Epilepsy
1 other identifier
observational
62
0 countries
N/A
Brief Summary
Epilepsy is defined as a chronic disorder that presents with recurrent episodes of unprovoked seizures. Epileptic seizures are caused by excessive excitation of cortical neurons. The condition has various etiologies and comorbidities. Classification; The Classification of Epilepsies includes several diagnostic levels (steps):
- 1.from seizure type to epilepsy type (generalized/focal/combined generalized and focal/unknown)
- 2.etiology (genetic/ structural/ infectious/ metabolic/ immune/unknown). A clinician can use any level of the classification
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Dec 2023
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2023
CompletedStudy Start
First participant enrolled
December 30, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2025
CompletedJanuary 8, 2024
January 1, 2024
1 year
November 20, 2023
January 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Psychiatric comorbidities in children with generalized epilepsy
Measuring the prevalence of ADHD and Autism among children suffering from generalized epilepsy .All cases included in the study will be evaluated by: * full history including neurological history . * full examination including neurological examination . * Investigations: * EEG * ADHD Symptom Checklist-4 (ADHD-SC4( \[8\] * Gilliam Autism Rating scale ( GARS) \[9\] Sample size calculation: Based on determining the main outcome variable, the estimated minimum required total sample size is 62 participants . Main outcome variable: to evaluate phsycatric complications among epilitic pediatric patients. based on previous study, (40%) and (11-30%) ADHD and Autisim In epilitic children respectively . \[10-11\] Main statistical test is chi square to detect the difference in percentage of physiatric disorders( ADHD and Autism) in the two groups . Alpha error = 0.05 Power = 0.80 Allocation ratio= 1 One tailed.
baseline
Eligibility Criteria
psychiatric comorbidities in children with generalized epilepsy
You may qualify if:
- Patients with generalized epilepsy either new or old ,controlled or un controlled .
- School aged patients (from 6 years to 17 years).
- Patients on anti epileptic treatment .
- Patients attending children's neurological unit .
You may not qualify if:
- \- children with other types of epilepsy .
- children with cerebral palsy.
- children with neurodegenerative disease.
- children with neurometabolic disease.
- mentally retarded children.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor
Study Record Dates
First Submitted
November 20, 2023
First Posted
January 8, 2024
Study Start
December 30, 2023
Primary Completion
December 31, 2024
Study Completion
March 24, 2025
Last Updated
January 8, 2024
Record last verified: 2024-01