- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prevalence of Primary Headache Disorders
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .