Early Identification of Brain Lesions in Multiple Sclerosis With Phase Sensitive Inversion Recovery MRI

NCT06955832 · tracked via the Priya Life Science Egypt tracker

Sponsor

Benha University

Phase

Observational

Started

2025-06

Last updated

2025-05-18

Condition(s) studied

Multiple Sclerosis

Study 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.

Eligibility

Sex

ALL

Min age

15 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Age between 15-65 years. * Both sexes. * Patients with MS according to McDonald Criterion Exclusion Criteria: * Age less than 15 years old. * Patients with stroke or previous intracranial hemorrhage. * Contraindications to MRI scans. * MS mimics.

Primary outcome measure(s)

Number and classification of cortical lesions — 18 months
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).

Trial sites (3)

Facility	City	Region	Status
Banha University Hospitals	Banhā	Qalyubia Governorate	Recruiting
El Mounira Multiple Sclerosis Unit	Cairo	Egypt	Recruiting
Naser Institute MS Unit	Cairo	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06955832 on ClinicalTrials.gov ↗ ← All trials in Egypt