Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple

NCT ID: NCT06435962

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-03-01

Brief Summary

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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

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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.

Conditions

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Relapsing Remitting Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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sonography

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

Intervention Type DEVICE

Other Intervention Names

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visual evoked potential( VEP)

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Randa Alkady

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anwar M Ali, professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Randa A Mohamed, resident

Role: CONTACT

01123668059

Anwar M Ali, professor

Role: CONTACT

01030361010

References

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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.

Reference Type BACKGROUND
PMID: 31564882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27639433 (View on PubMed)

Other Identifiers

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optic nerve affection in RRMS

Identifier Type: -

Identifier Source: org_study_id

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