Prevalence of Primary Headache Among Patients With Multiple Sclerosis in Assiut University Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Prevalence of Primary Headache Disorders
研究概览
简要总结
Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system that can cause a wide range of neurological symptoms. Headache is increasingly recognized as a common yet frequently overlooked symptom that significantly impairs quality of life and daily functioning in people with MS. While international reports suggest a high frequency of primary headache disorders, primarily migraine and tension-type headache, in individuals with MS, data evaluating headache patterns among Egyptian MS patients remain limited.
The purpose of this observational study is to determine the prevalence and specific types of primary headache disorders among adults with MS attending Assiut University Hospitals, classified according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). The study also aims to evaluate how headache disorders relate to patient demographics, MS disease duration and phenotype, neurological disability, MRI lesion characteristics, disease-modifying therapies, cognitive function, anxiety, and depression.
Participants will complete a single-visit cross-sectional evaluation consisting of:
- A detailed clinical interview and neurological examination covering medical history, MS course, and headache characteristics.
- Neurological disability scoring using the Expanded Disability Status Scale (EDSS).
- Review of brain and spinal cord magnetic resonance imaging (MRI) scans.
- Standardized assessments for cognitive performance (Montreal Cognitive Assessment [MoCA]), anxiety (Hamilton Anxiety Rating Scale [HAM-A]), and depression (Hamilton Depression Rating Scale [HAM-D]).
No experimental medications or procedural interventions are administered as part of this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older
- •Confirmed diagnosis of multiple sclerosis according to the McDonald diagnostic criteria
- •Any clinical multiple sclerosis phenotype, including Relapsing-Remitting MS (RRMS), Secondary Progressive MS (SPMS), or Primary Progressive MS (PPMS)
- •Patients attending the Multiple Sclerosis Clinic or admitted to the Department of Neurology and Psychiatry at Assiut University Hospitals during the study period
- •Ability to understand study procedures and provide written informed consent
排除标准
- •Other inflammatory demyelinating disorders of the central nervous system (e.g., neuromyelitis optica spectrum disorder [NMOSD] or myelin oligodendrocyte glycoprotein antibody-associated disease [MOGAD])
- •Secondary headache attributable to identifiable non-MS etiologies, including intracranial tumors, central nervous system infections, acute cerebrovascular disease, idiopathic intracranial hypertension, or cerebral venous sinus thrombosis
- •Severe cognitive impairment or active psychiatric disorder precluding reliable clinical history-taking or completion of the structured headache assessment
- •Incomplete clinical or radiological records
研究组 & 干预措施
Multiple Sclerosis Patients
Adult patients aged 18 years or older with a confirmed diagnosis of multiple sclerosis (including relapsing-remitting, secondary progressive, and primary progressive phenotypes) attending the Multiple Sclerosis Clinic or admitted to the Department of Neurology and Psychiatry at Assiut University Hospitals.
All participants undergo clinical evaluation, neurological assessment, Expanded Disability Status Scale (EDSS) scoring, brain and spinal cord MRI, and diagnostic headache classification using the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria. Additional psychometric and cognitive assessments include the Montreal Cognitive Assessment (MoCA), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), and Eysenck Personality Questionnaire (EPQ).
结局指标
主要结局
Prevalence of Primary Headache Disorders
时间窗: Baseline
Percentage of patients with multiple sclerosis diagnosed with any primary headache disorder according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria. Diagnoses are established through structured clinical interviews, comprehensive headache history, and neurological examination.
次要结局
未报告次要终点
研究者
Mohamed Ahmed Abd Elnaby Elsayed
Resident of Neurology and Psychiatry
Assiut University