Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-30 @ 1:36 PM
Study NCT ID:
NCT06868251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Pattern of Headache in Pediatric Epilepsy
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Prevalence and Pattern of Comorbid Headache in Pediatric Epilepsy Patients Attending Assiut University Children Hospital.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to determine the prevalence and characteristics of headaches in children with epilepsy, aged 5-18 years. Approximately 60 children will participate at Assiut University Children's Hospital. The research will involve medical history collection, physical and neurological exams, EEG review, and blood tests. The study seeks to improve understanding of the relationship between epilepsy and headaches in children, potentially leading to better treatment strategies. Participation is voluntary, and the risks are minimal.
Detailed Description:
The primary aim of this observational cross-sectional study is to estimate the prevalence and characterize headaches in pediatric epilepsy patients. Secondary objectives include identifying potential risk factors and triggers associated with headaches in this population and assessing their impact on quality of life.
Participant Criteria
Inclusion criteria:
Children aged 5-18 years with epilepsy
Mentally normal and able to describe symptoms
Willing to participate in the study
Exclusion criteria:
Children unable to express symptoms due to mental retardation, psychiatric illness, or verbal disability
Children or parents who refuse to participate
Methodology Sample Size: 60 patients, calculated using Epi-info version 7 software, based on a previous study showing 45.7% headache prevalence in pediatric epilepsy patients.
Data Collection:
Detailed medical history, including neurological, cardiovascular, gastrointestinal, endocrine, and musculoskeletal aspects
Comprehensive headache history (onset, location, intensity, quality, duration, frequency, associated symptoms)
Epilepsy history (age of onset, duration, type, medication, seizure control)
General physical examination
Neurological examination
Investigations:
Electroencephalogram (EEG) using Nihon Kohden model 1200
Neuroimaging studies (MRI, CT) if available
Complete Blood Count (CBC)
Participant Criteria
Inclusion criteria:
Children aged 5-18 years with epilepsy
Mentally normal and able to describe symptoms
Willing to participate in the study
Exclusion criteria:
Children unable to express symptoms due to mental retardation, psychiatric illness, or verbal disability
Children or parents who refuse to participate
Methodology Sample Size: 60 patients, calculated using Epi-info version 7 software, based on a previous study showing 45.7% headache prevalence in pediatric epilepsy patients.
Data Collection:
Detailed medical history, including neurological, cardiovascular, gastrointestinal, endocrine, and musculoskeletal aspects
Comprehensive headache history (onset, location, intensity, quality, duration, frequency, associated symptoms)
Epilepsy history (age of onset, duration, type, medication, seizure control)
General physical examination
Neurological examination
Investigations:
Electroencephalogram (EEG) using Nihon Kohden model 1200
Neuroimaging studies (MRI, CT) if available
Complete Blood Count (CBC)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: