Prevalence of Primary Headache in Multiple Sclerosis Patients

ConditionsMultiple Sclerosis Primary Headache Disorders Migraine Disorders Tension-Type Headache

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adult patients aged 18 years and older diagnosed with multiple sclerosis (including relapsing-remitting, secondary progressive, and primary progressive phenotypes) who attend the Multiple Sclerosis Clinic or are admitted to the Department of Neurology and Psychiatry at Assiut University Hospitals during the one-year study period.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants

are grouped into 1 trial group

Group A: Multiple Sclerosis Patients

Trial outcomes

Primary outcomes

Prevalence of Primary Headache Disorders

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.

Time frame

Baseline

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: