An observational study in Headache Disorders and Epilepsy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by Assiut University · Observational
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.
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)
145 studies on the registry are indexed under Headache Disorders; 37 are open to participants now.
This study's planned enrollment of 60 is below the median of 131 across 46 observational studies indexed under Headache Disorders.
Browse Headache Disorders studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms and have epilepsy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
2/ Acceptance to participate in this study.
Exclusion Criteria:
2/ Children or Parents who refused to participate in this study.
This group consists of children aged 5-18 years with diagnosed epilepsy who are mentally normal and can describe their symptoms. The study aims to estimate the prevalence and characteristics of headache in these patients. Participants will undergo a comprehensive evaluation including medical history, physical and neurological examinations, and investigations such as EEG and neuroimaging. The research will assess various aspects of headache in relation to epilepsy, including onset, location, intensity, duration, and relationship to seizures, to better understand the comorbidity between headache and epilepsy in pediatric patients.
headache prevelance
To estimate the prevalence and characters of headache in pediatric epileptic patients
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Sep 2026, 16 months later.
Of 21 observational studies under Headache Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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