Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Device: sonography

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Randa A Mohamed, resident; Phone Number: 01123668059; Email: randaalkady07@gmail.com
• Study Contact Backup: Name: Anwar M Ali, professor; Phone Number: 01030361010; Email: anwarmoha2006@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

both sex and RRMS with out previous optic neuritis

Description

1. inclusion criteria

   1. both sex
   2. Age group from 15 to 50 yrs
   3. Patient with RRMS without history of optic neuritis

2. Exclusion criteria :

   1. History of previous optic neuritis
   2. Medical illness of eye(e.g. diabetes and hypertension)
   3. MS patient on fingolimod for 6 months or more
   4. Relapsing or use of steroid in the past 3 months
   5. Proved alternative diagnosis (neuromyelitis optica )
   6. local eye disease or surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Anwar M Ali, professor, Assiut University

Publications and helpful links

General Publications

• Koraysha NA, Kishk N, Hassan A, Samy El Gendy NM, Shehata HS, Al-Azayem SA, Kamal YS. Evaluating optic nerve diameter as a possible biomarker for disability in patients with multiple sclerosis. Neuropsychiatr Dis Treat. 2019 Sep 6;15:2571-2578. doi: 10.2147/NDT.S216079. eCollection 2019.
• De Masi R, Orlando S, Conte A, Pasca S, Scarpello R, Spagnolo P, Muscella A, De Donno A. Transbulbar B-Mode Sonography in Multiple Sclerosis: Clinical and Biological Relevance. Ultrasound Med Biol. 2016 Dec;42(12):3037-3042. doi: 10.1016/j.ultrasmedbio.2016.07.018. Epub 2016 Sep 15.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: optic nerve affection in RRMS

Drug and device information, study documents

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