Prevalence of Primary Headache in Multiple Sclerosis Patients

NCT07826221 | Not Yet Recruiting

• 1 other identifier: Headache Prevalence in MS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis; Migraine Disorders; Tension-Type Headache; Primary Headache Disorders

Keywords

Multiple Sclerosis; Primary Headache; ICHD-3; EDSS; Disease-Modifying Therapies; MoCA; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Multiple Sclerosis; Headache Disorders, Primary; Migraine Disorders; Tension-Type Headache; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Neurology and Psychiatry

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09