Relapsing Remitting Multiple SclerosisNCT06435962
Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple
An observational study of Relapsing Remitting Multiple Sclerosis, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- sonography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: both sex and RRMS with out previous optic neuritis
- inclusion criteria
- both sex
- Age group from 15 to 50 yrs
- Patient with RRMS without history of optic neuritis
- Exclusion criteria :
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the 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.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- sonography
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonographyDevice
Also called visual evoked potential( VEP)
measurement of optic nerve in RRMS by sonography and visual evoked potential( VEP) as correlation of axonal affection in RRMS patient
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Alkady, Assiut University
- Investigators
- Anwar M Ali, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435962
- Sponsor's protocol ID
- optic nerve affection in RRMS
- Status last verified
- Jun 2024
- First submitted
- 2 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31564882De 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.
PubMed 27639433
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Productive Value of Sonographic Measurement of Optic Nerve in Transitional Multiple
- ClinicalTrials.gov ID
- NCT06435962
- Acronym / sponsor ID
- optic nerve affection in RRMS
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- both sex and RRMS with out previous optic neuritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonographyAlso: visual evoked potential( VEP)measurement of optic nerve in RRMS by sonography and visual evoked potential( VEP) as correlation of axonal affection in RRMS patient | Device | – |
Primary outcome
optic nerve measurement and correlation with axonal affection in RRMS
Time frame: baseline
measurement of optic nerve diameter and optic nerve sheath diameter (in millimeter) in predicting progression in RRMS (Relapsing remitting multiple sclerosis)
1 secondary outcome
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
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 31564882Koraysha 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.
- Background: PubMed 27639433De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anwar M Ali, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Randa A Mohamed, resident (01123668059, randaalkady07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optic nerve measurement and correlation with axonal affection in RRMS (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06435962, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.