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

White Matter Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in Patients With Relapsing Remitting Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Diagnostic test: VolBrain, a fully automated platform to generate the volumetric data (lesion count, volume and location as well as different atrophy measures); Other: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)

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 Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 11517
    • Eman Khedr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with relapsing remitting multiple sclerosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The relation of white matter lesion load, location and parameters of cognitive function measured by BICAMS	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	6 months
The relation of white matter lesion load, location and Fatigue in patients with relapsing remitting multiple sclerosis	correlation between fatigue severity, with white matter lesion load, and distribution in order to identify predictors of fatigue	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Eman M Khedr, professor, Assuit University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: lesion load and distribution

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No