Early Identification of Brain Lesions in Multiple Sclerosis With Phase Sensitive Inversion Recovery MRI
1 other identifier
observational
30
1 country
3
Brief Summary
The goal of this observational study is to compare the diagnostic accuracy of Phase-Sensitive Inversion Recovery (PSIR) MRI versus conventional T2-weighted (T2W) and Fluid Attenuated Inversion Recovery (FLAIR) sequences in detecting early brain lesions in patients with Multiple Sclerosis (MS). The study will include male and female participants aged 15-65 years diagnosed with MS per the 2017 McDonald criteria. This study hypothesizes that:
- PSIR MRI will detect a significantly higher number of cortical lesions (intracortical, leukocortical, and juxtacortical) compared to conventional T2W and FLAIR sequences in MS patients (p \< 0.05).
- Lesions identified exclusively by PSIR will correlate more strongly with clinical measures (EDSS disability scores and SDMT cognitive performance) than those detected by T2W/FLAIR alone, suggesting PSIR's superior sensitivity to clinically relevant pathology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2025
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
May 2, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedMay 18, 2025
May 1, 2025
Same day
April 25, 2025
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and classification of cortical lesions
Total cortical lesion count (sum of intracortical \[IC\], leukocortical \[LC\], and juxtacortical \[JC\] lesions) detected by each MRI sequence (PSIR vs. T2W vs. FLAIR), assessed by two independent neuroradiologists.. Lesion subtype distribution: * IC lesions (confined to gray matter). * LC lesions (spanning gray-white matter). * JC lesions (subcortical U-fiber involvement).
18 months
Eligibility Criteria
This study will enroll participants from three clinical sites in Egypt: * Neurology Department, Banha University Hospitals (Benha, Qalyubia Governorate). * El Mounira MS Unit (Cairo). * Naser Specialized Hospital MS Unit (Cairo). Recruitment Setting: * Outpatient MS clinics at all three sites * Inpatient neurology services at Banha University Hospitals
You may qualify if:
- Age between 15-65 years.
- Both sexes.
- Patients with MS according to McDonald Criterion
You may not qualify if:
- Age less than 15 years old.
- Patients with stroke or previous intracranial hemorrhage.
- Contraindications to MRI scans.
- MS mimics.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (3)
Banha University Hospitals
Banhā, Qalyubia Governorate, Egypt
El Mounira Multiple Sclerosis Unit
Cairo, Egypt
Naser Institute MS Unit
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurology Specialist
Study Record Dates
First Submitted
April 25, 2025
First Posted
May 2, 2025
Study Start
June 1, 2025
Primary Completion
June 1, 2025
Study Completion
October 1, 2025
Last Updated
May 18, 2025
Record last verified: 2025-05