Prevalence and Pattern of Headache in Pediatric Epilepsy

NCT ID: NCT06868251

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-30

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)

Conditions

Headache Disorders; Epilepsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

pediatric epilepsy patients with headache

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Somia Rasheed Abdelrasoul

resident at the pediatrics department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

headache in pediatric epilipsy

Identifier Type: -

Identifier Source: org_study_id