## Protocol Section
### Identification Module
**NCT ID:** NCT06435962

**Brief Title:** Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple

**Official Title:** Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple

#### Organization Study ID Info
**ID:** ON affection in RRMS
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2026-03-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-02
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Randa Alkady

**Investigator Title:** resident doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 1.to evaluate the potential role of the 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 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 aptic nerve function buly 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 ON) and, to a lesser extent, in un affected eye Also the VEPs study has the ability to quantify the unsuspected clinically silent lesions, hence, allows confirming the vague deterioration of visual functions.

### Conditions Module

**Conditions:**

- Optic Nerve Affection in RRMS

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** measurement of optic nerve in RRMS by sonography and VEP as correlation of axonal affection in RRMS patient

**Name:** sonography

**Other Names:**

- VEP

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** To evaluate the potential role of optic nerve diameter and optic nerve sheath diameter and ratio(in millimeter) in predicting progression in RRMS

**Measure:** optic nerve measurement and correlation with axonal affection in RRMS

**Time Frame:** basline

#### Secondary Outcomes

**Measure:** 2.Correlation of US and VEP value(change in p100 latency) with physical disability and cognitive score and fatigue by MSFC and FSS

**Time Frame:** Basline

### Eligibility Module

**Eligibility Criteria:** 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. D.M \&HTN
   3. Druges of eyes including MS patient on fingolimod for 6 months or more
   4. Relapsing or use of steroid in the past 3 months
   5. Proved alternative diagnosis (NMO)
   6. local eye disease or surgery

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 15 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** both sex and RRMS with out previous optic neuritis

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** randaalkady07@gmail.com

**Name:** Randa A Mohamed, resident

**Phone:** 01123668059

**Role:** CONTACT

**Contact 2:**

**Email:** anwarmoha2006@yahoo.com

**Name:** Anwar M Ali, professor

**Phone:** 01030361010

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Assiut University

**Name:** Anwar M Ali, professor

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 31564882

**Citation:** 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.

**PMID:** 27639433

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
