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- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prevalence of Primary Headache Disorders
Periodo de tiempo: 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.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Síntomas de comportamiento
- Enfermedades Autoinmunes Desmielinizantes, SNC
- Enfermedades Autoinmunes del Sistema Nervioso
- Enfermedades desmielinizantes
- Trastornos de dolor de cabeza
- Comportamiento
- Desórdenes de ansiedad
- Esclerosis múltiple
- Trastornos de migraña
- Depresión
- Dolor de cabeza tipo tensión
- Trastornos de cefalea primaria
Otros números de identificación del estudio
- Headache Prevalence in MS
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