Clinical trial NCT06868251: Prevalence and Pattern of Headache in Pediatric Epilepsy
Official title: Prevalence and Pattern of Comorbid Headache in Pediatric Epilepsy Patients Attending Assiut University Children Hospital.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Headache Disorders
Epilepsy
Keywords: epilepsy
headache
pediatric epilepsy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms and have epilepsy

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)

Eligibility criteria: Inclusion Criteria:

- pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms.

2/ Acceptance to participate in this study.

Exclusion Criteria:

- / Children who can't express their symptoms properly because of mental retardation, psychiatric illness or verbal disability.

2/ Children or Parents who refused to participate in this study.

Primary outcomes:
measure: headache prevelance
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: