Psychiatric ComorbiditiesNCT06194422
Psychiatric Comorbidities in Children With Generalized Epilepsy
An observational study of Psychiatric Comorbidities, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Psychiatric Comorbidities
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2023to 24 Mar 2025
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- Child
Study population: psychiatric comorbidities in children with generalized epilepsy
Who may be able to join
- 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 .
Who cannot join
- - children with other types of epilepsy .
- -children with cerebral palsy.
- -children with neurodegenerative disease.
- -children with neurometabolic disease.
- -mentally retarded children.
About this study
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
Read the 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
- Conditions
- Psychiatric Comorbidities
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start30 Dec 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion24 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric ComorbiditiesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Gamal Hashem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194422
- Sponsor's protocol ID
- psychiatric change in children
- Status last verified
- Jan 2024
- First submitted
- 20 Nov 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Comorbidities in Children With Generalized Epilepsy
- ClinicalTrials.gov ID
- NCT06194422
- Acronym / sponsor ID
- psychiatric change in children
- Conditions
- Psychiatric Comorbidities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 24 Mar 2025 (estimated)
- First posted
- 8 Jan 2024 (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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- psychiatric comorbidities in children with generalized epilepsy
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (5 listed)
- - children with other types of epilepsy .
- -children with cerebral palsy.
- -children with neurodegenerative disease.
- -children with neurometabolic disease.
- -mentally retarded children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: * 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Comorbidities, run by Assiut 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jan 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?
Results are not available in the source record.
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?
Psychiatric comorbidities in children with generalized epilepsy (time frame: baseline). 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 8 Jan 2024; AzTrials last refreshed its copy on 1 Nov 2026.