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

NCT05604092 | Completed

• 1 other identifier: lesion load and distribution
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• the relation of white matter lesion load, location and atrophy parameters to physical disability in patients with relapsing remitting multiple sclerosis

  6 months

Interventions

VolBrain, a fully automated platform to generate the volumetric data (lesion count, volume and location as well as different atrophy measures) DIAGNOSTIC_TEST

VolBrain, a fully automated platform that uses anonymized compressed NIFTI files to generate the volumetric data. Volbrain is increasingly recognized and compared to other volumetric tools. LesionBrain is a pipeline to automatically segment WM-L from T1 and FLAIR data. Number of lesions, absolute total lesion volume (in cubic cm), normalized lesion volume (percentage of total lesion volume to whole brain volume), lesion burden (percentage of total WM lesion volume to WM volume), and location (Periventricular, Juxtacortical, and Infratentorial) were obtained.

Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) OTHER

It includes the Symbol Digit Modalities Test (SDMT) for evaluating the information processing speed, the California Verbal Learning Test (CVLT-II) for evaluating verbal learning and memory, and the Brief Visual Memory Test (BVMT) for evaluating visual learning and memory. Cut off values were calculated as 1.5 SD below mean according to a group of healthy individuals who are matched in age, sex and education as following: 22 for SDMT, 38 for CVLT, and 10 for BVMTR

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with relapsing remitting multiple sclerosis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Eman Khedr

Asyut, 11517, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eman M Khedr, professor

  Assuit university hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 3, 2022
• Study Start: March 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)