Psychiatric Comorbidities Clinical Trial
Official title:
Psychiatric Comorbidities in Children With Generalized Epilepsy
Verified date | January 2024 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | March 24, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | Inclusion Criteria: 1. Patients with generalized epilepsy either new or old ,controlled or un controlled . 2. School aged patients (from 6 years to 17 years). 3. Patients on anti epileptic treatment . 4. Patients attending children's neurological unit . Exclusion Criteria: 1. - children with other types of epilepsy . 2. -children with cerebral palsy. 3. -children with neurodegenerative disease. 4. -children with neurometabolic disease. 5. -mentally retarded children. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 |
Status | Clinical Trial | Phase | |
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Recruiting |
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French Validation of the Dual Diagnosis Screening Interview (F_DDSI)
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