Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple

NCT06435962 | Not Yet Recruiting DMC

• 1 other identifier: optic nerve affection in RRMS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

sonography DEVICE

measurement of optic nerve in RRMS by sonography and visual evoked potential( VEP) as correlation of axonal affection in RRMS patient

Also known as: visual evoked potential( VEP)

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

both sex and RRMS with out previous optic neuritis

You may qualify if:

• both sex
• Age group from 15 to 50 yrs
• Patient with RRMS without history of optic neuritis

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anwar M Ali, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Randa A Mohamed, resident

CONTACT

01123668059; randaalkady07@gmail.com

Anwar M Ali, professor

CONTACT

01030361010; anwarmoha2006@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: May 30, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06