Clinical trial NCT05604092: Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in RRMS
Official title: White Matter Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in Patients With Relapsing Remitting Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with relapsing remitting multiple sclerosis

Brief summary: In relapsing remitting multiple sclerosis (RRMS) the relationship between cognitive impairment (CI), fatigue and physical disability with white matter lesion load (WM-LL), location among other volumetric measures using automated platforms is still unclear.

Detailed description: Cognitive impairment (CI) and fatigue have been recognized as an important feature of MS, affecting up to 70% patients (1), evident since onset and increase in both prevalence and severity as the disease progresses (2). In fact, their effects on patients and even their caregivers are more pronounced than clinical disability, causing unemployment, treatment non-adherence, personality changes as well as several psychosocial dysfunctions (3-5). Therefore, beside evaluating the physical disability, it is essential for health professionals to objectively evaluate either the cognitive function or fatigue at both baseline and during routine follow up visits for early detection and management (6). Through the advances in MRI techniques and availability of a number of automated software, quantitative radiological assessments became more readily available and feasible in daily practice (7) allowing objective longitudinal monitoring of patients (8,9). Although burden and location of lesions in RRMS is thought to be associated with cognitive impairment (CI), fatigue and physical disability, some controversy results were obtained from previous studies. So, by conducting this study, we aimed at exploring the relationship between different parameters of lesion load and location with fatigue, cognitive and physical disability in RRMS patients.

Eligibility criteria: Inclusion Criteria:

* : adult patients of both sexes diagnosed with RRMS according to 2017 McDonald diagnostic criteria

Exclusion Criteria:

* Patients with relapse or steroid administration in the past 30 days were excluded. Patients who have any medical conditions that may affect cognition, and those on psychoactive pharmacotherapy were also excluded.

Primary outcomes:
measure: The relation of white matter lesion load, location and parameters of cognitive function measured by BICAMS
timeFrame: 6 months
measure: The relation of white matter lesion load, location and Fatigue in patients with relapsing remitting multiple sclerosis
timeFrame: 6 months
Secondary outcomes:
measure: the relation of white matter lesion load, location and atrophy parameters to physical disability in patients with relapsing remitting multiple sclerosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Eman Khedr
Study officials:
affiliation: Assuit university hospital
name: Eman M Khedr, professor
role: PRINCIPAL_INVESTIGATOR
References: