Headache DisordersNCT06868251
Prevalence and Pattern of Headache in Pediatric Epilepsy
An observational study of Headache Disorders and Epilepsy, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Headache Disorders, Epilepsy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms and have epilepsy
Who may be able to join
- pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms.
- 2/ Acceptance to participate in this study.
Who cannot join
- / 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.
About this study
Official title: Prevalence and Pattern of Comorbid Headache in Pediatric Epilepsy Patients Attending Assiut University Children Hospital.
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.
Read the 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
- Keywords
- epilepsy, headache, pediatric epilepsy
- Medical subject headings
- Headache Disorders, Epilepsy, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
headache prevelance
To estimate the prevalence and characters of headache in pediatric epileptic patients
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Somia Rasheed Abdelrasoul, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868251
- Sponsor's protocol ID
- headache in pediatric epilipsy
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Pattern of Comorbid Headache in Pediatric Epilepsy Patients Attending Assiut University Children Hospital.
- ClinicalTrials.gov ID
- NCT06868251
- Acronym / sponsor ID
- headache in pediatric epilipsy
- Conditions
- Headache Disorders, Epilepsy
- Keywords
- epilepsy, headache, pediatric epilepsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms and have epilepsy
Key inclusion criteria (2 listed)
- pediatric epilepsy patients (5:18 years of age) who are mentally normal and can describe their symptoms.
- 2/ Acceptance to participate in this study.
Key exclusion criteria (2 listed)
- / 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
headache prevelance
Time frame: 1 month
To estimate the prevalence and characters of headache in pediatric epileptic patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache Disorders and Epilepsy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
headache prevelance (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.