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- Ensaio Clínico NCT07826221
Prevalence of Primary Headache in Multiple Sclerosis Patients
Prevalence of Primary Headache Among Patients With Multiple Sclerosis in Assiut University Hospitals
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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Prevalence of Primary Headache Disorders
Prazo: Baseline
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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.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Doenças autoimunes
- Doenças do sistema imunológico
- Sintomas Comportamentais
- Doenças Autoimunes Desmielinizantes, SNC
- Doenças Autoimunes do Sistema Nervoso
- Doenças Desmielinizantes
- Distúrbios de dor de cabeça
- Comportamento
- Transtornos de ansiedade
- Esclerose múltipla
- Transtornos de Enxaqueca
- Depressão
- Cefaléia do Tipo Tensional
- Cefaleias Primárias
Outros números de identificação do estudo
- Headache Prevalence in MS
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