- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06194422
Psychiatric Comorbidities in Children With Generalized Epilepsy
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):
- from seizure type to epilepsy type (generalized/focal/combined generalized and focal/unknown)
- etiology (genetic/ structural/ infectious/ metabolic/ immune/unknown). A clinician can use any level of the classification
Study Overview
Status
Conditions
Detailed Description
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):
- from seizure type to epilepsy type (generalized/focal/combined generalized and focal/unknown)
- etiology (genetic/ structural/ infectious/ metabolic/ immune/unknown). A clinician can use any level of the classification. Seizures are classified by the onset (focal, generalized or unknown). All types of seizures can be motor or nonmotor.
Focal seizure may evolve to bilateral tonic-clonic (previously called secondary-generalized). Atonic, clonic, tonic, myoclonic seizures and epileptic spasms can be either of focal or generalized onset.
Unclassified type of seizure was introduced. Most common psychiatric manifestations ; Common psychiatric disorders that have been reported among patients with un controlled generalized epilepsy include :
- Anxiety.
- Depression.
- Attention-deficit hyperactivity disorder.
- Autism. Psychological distress may be the strongest predictor of health-related quality of life, even including seizure frequency and severity , employment or driving status. Affective disorders are overrepresented in epilepsy, and people with epilepsy may be at risk of dropping out from school. The aim of the present study was to assess factors influencing high school dropout, anxiety, and depression in genetic generalized epilepsy (GGE). Potential predictors of high school dropout were analyzed with logistic regression. Having felt excluded because of epilepsy was significantly associated with high school dropout The issue of stigma in epilepsy must be thoroughly addressed in comprehensive care and may be as important as seizure control when it comes to education and quality of life Attention deficit is one of the most frequent symptoms in children with idiopathic generalized epilepsy (IGE).
However, it is unknown whether this is a global attention deficit or a deficit in a specific attention network. We used the attention network test (ANT) in children with IGE, who were not being treated with antiepileptic drugs (AEDs), to determine the efficiencies of three independent attention networks (alerting, orienting, and executive control). Children with IGE showed a significant deficit in their executive control network and in overall reaction time. However, they did not show any deficit in their alerting or orienting networks. These results suggest that IGE specifically affects the executive control network. Autism spectrum disorders (ASD) are neurodevelopmental disorders typically diagnosed in childhood, characterized by core social dysfunction, rigid and repetitive behaviors, restricted interests, and abnormal sensorial sensitivity. ASD associated with neurological conditions: the co-occurrence of epilepsy is well documented and there is also evidence of a higher prevalence of EEG abnormalities with 4-86% of individuals with ASD presenting epileptiform or not epileptiform EEG abnormalities. The presence of epilepsy in people with ASD may be determined by several structural alterations, genetic conditions, or metabolic dysfunctions, known to play a role in the emergence of both epilepsy and autis
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 .
Exclusion Criteria:
- - children with other types of epilepsy .
- -children with cerebral palsy.
- -children with neurodegenerative disease.
- -children with neurometabolic disease.
- -mentally retarded children.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychiatric comorbidities in children with generalized epilepsy
Time Frame: baseline
|
Measuring the prevalence of ADHD and Autism among children suffering from generalized epilepsy .All cases included in the study will be evaluated by:
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- psychiatric change in children
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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