Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome

Multiple Sclerosis Clinical Trial

— HdeFIMS  

Official title:

Evaluation of the Predictive Value of the Optic Nerve Involvement at the Stage of Clinically Isolated Syndrome, for the Diagnosis of Clinically Definite Multiple Sclerosis and the Delay of Second Relapses' Occurrence

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455332
• Other study ID #: 2021_0474
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2028

Study information

• Verified date: May 2024
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Optic neuritis (ON) represents around 30% of clinical presentation of clinically isolated syndrome (CIS). Asymptomatic optic nerve involvement is very frequent in all stage of multiple sclerosis (MS) disease including the CIS. However, optic nerve is still not part of MS diagnosis criteria. The main objective of our regional and multicenter study is to evaluate the prognostic value of optic nerve involvement at the earliest clinical stage of MS (=CIS) for the diagnosis of clinically definite MS (2nd clinical relapse) and the delay until the 2nd relapse.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients between 18 and 55 years old
• Occurrence of CIS = 6 months
• With two T2 hypersignals on brain/spinal cord MRI suggestive of MS or with oligoclonal bands
• Giving their written informed consent

Exclusion Criteria:

• Pathological conditions that may skew the optic nerve MRI and/or retinal OCT (diabetes mellitus, glaucoma, retinopathy, ametropia >6 dioptria)
• Past history of MS relapses
• Extensive myelitis (>3 vertebral bodies)
• Bilateral optic neuritis without T2 lesions suggestive of MS
• Contra-indication to MRI, gadolinium injection
• Pregnancy, breast-feeding
• Patients unable to consent

Related Conditions & MeSH terms

• Clinically Isolated Syndrome
• Multiple Sclerosis
• Sclerosis
• Syndrome

Intervention

Other:
• Optic nerve MRI sequence
Systematic optic nerve MRI sequence during the CIS diagnosis work-up. This sequence is not done systematically and not recommended for now (except in case of acute ON). The interventional nature of the study remains minimal

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Lille	All hospitals from Région des Hauts-de-France (n=20), Région des Hauts-de-France, University Hospital of Lille and Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optic nerve involvement defined by occurrence of a recent clinical episode of ON		assessed at baseline
Primary	Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)		assessed at baseline
Primary	Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a second MS clinical relapse		assessed every 6 months during 24 months
Primary	Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)		assessed at baseline
Primary	Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS		assessed every 6 months during 24 months
Secondary	Asymptomatic optic nerve involvement will be defined by: - asymptomatic optic nerve T2 hypersignal detected on one or both optic nerve(s) - or by GCIPL-IETD,3pm measured by OCT - or by GCIPL-IETD=3µm measured by OCT	Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination (M0, M6, M12, M18, M24)	assessed at baseline every 6 months during 24 months
Secondary	Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination		assessed at Month 0, Month 6, Month 12, Month 18, Month 24