Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT06868251
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)
Study:
NCT06868251
Study Brief:
Protocol Section:
NCT06868251