Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial
NCT06170281
Brain Diseases, Central Nervous System Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT Number: NCT06868251
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.
Trial opening soon.
Get Notified5 year–18 year
All sexes
Observational
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
2/ Acceptance to participate in this study.
Exclusion criteria
2/ Children or Parents who refused to participate in this study.
Time frame: 1 month
To estimate the prevalence and characters of headache in pediatric epileptic patients
Assiut University
Other
Prevalence and Pattern of Comorbid Headache in Pediatric Epilepsy Patients Attending Assiut University Children Hospital.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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