Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple

Not yet recruiting

• Conditions: Relapsing Remitting Multiple Sclerosis

• Registration Number: NCT06435962
• Lead Sponsor: Assiut University

Brief Summary

1.to evaluate the potential role of the optic nerve diameter ( OND determined by ultrasonography and and visual nerve function by visual evoked potential as a biomarker of early axonal loss and disability in patients with relapsing remitting multiple sclerosis (RRMS).

Detailed Description

Multiple sclerosis (MS) is one of the leading disabling neurological diseases in young Adults. Characteristically reliable biomarkers for every independent MS pathogenic factor are extremely important.

1 Increasing evidence has demonstrated that neuronal and axonal damage within the central nervous system (CNS) contributes substantially to the development of permanent disability in patients with MS

* 2 Thus, reliable, economic and easily assessable complementary surrogate biomarkers for axonal Degeneration and consequently disability remain to be identified

* 3 The optic nerve can serve as a useful clinical tool for studying these characteristics and can be used to Measure and monitor the pathological process of the disease. The optic nerve is most commonly assessed by ophthalmoscopy and magnetic resonance imaging (MRI), But measurement of the optic nerve diameter (OND) by a simple ultrasound examination and measurement of optic nerve function by visual evoked potential might permit a rough estimation of the extent of brain parenchymal involvement and the consequent global cerebral atrophy and disability In relapsing-remitting MS (RRMS) patients.

The analysis of the diameter of the optic nerve showed that it is possible To detect its atrophy in the affected eyes (with optic neuritis ) and, to a lesser extent, in un affected eye Also the visual evoked potential study has the ability to quantify the unsuspected clinically silent lesions, hence, allows confirming the vague deterioration of visual functions.

Study Timeline

• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-02
• Last Update Posted: 2024-06-04
• Study Start: 2024-08-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
optic nerve measurement and correlation with axonal affection in RRMS	baseline	measurement of optic nerve diameter and optic nerve sheath diameter (in millimeter) in predicting progression in RRMS (Relapsing remitting multiple sclerosis)

Secondary Outcome Measures

Name	Time	Method
2.Correlation of ultrasonography and visual evoked potential (change in p100 latency) with physical disability and cognitive score and fatigue by Multiple Sclerosis Functional Composite	Baseline	Correlation of ultrasonography and visual evoked potential (change in p100 latency) with physical disability and cognitive score and fatigue by Multiple Sclerosis Functional Composite The score is based on a combination of timed tests of walking, arm function, and cognitive ability An integrated Multiple Sclerosis Functional Composite (MSFC) score is calculated using z-scores