Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in RRMS

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis

• Registration Number: NCT05604092
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-27
• Study First Posted: 2022-11-03
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relation of white matter lesion load, location and parameters of cognitive function measured by BICAMS	6 months	correlation of BICAMS subtests scores to different parameters of white matter lesion load, distribution and load (volume and number of lesion) measurements (whole brain atrophy, grey matter and white matter lesion load) to identify best predictors of cognitive impairment
The relation of white matter lesion load, location and Fatigue in patients with relapsing remitting multiple sclerosis	6 months	correlation between fatigue severity, with white matter lesion load, and distribution in order to identify predictors of fatigue

Secondary Outcome Measures

Name	Time	Method
the relation of white matter lesion load, location and atrophy parameters to physical disability in patients with relapsing remitting multiple sclerosis	6 months	correlation of EDSS scores, with white matter lesion load and distribution

Trial Locations

Locations (1)

Eman Khedr; 🇪🇬 Assiut, Egypt