Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?

NCT ID: NCT03570385

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2022-06-24

Brief Summary

Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?

Conditions

Optic Neuritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with Optic Neuritis

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)

Interventions

MRI

MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 55 years old
• Clinically suspected optic neuritis defined as a sudden decrease of the visual acuity and/or a damage to the field of vision and/or a defect of the colour vision and/or retro-orbital pain with a relative afferent pupillary defect (except if the optic neuropathy is bilateral or symmetrical), in the absence of a severe retinal macular pathology, and in the absence of a toxic or iatrogenic intake (ethambutol, vfend)
• Clinical optic neuritis duration < 15 days
• First episode of an inflammatory ON
• No corticosteroids in the month before
• Indication to a corticosteroid therapy at high dose to cure the felt symptomatology
• Retinal nerve fibre layer (RNFL) thickness upper 75 µm at initial stage
• Isolated ON, multiple sclerosis or NMO (Neuro Myelitis Optica) - SD (Spectrum Disorder) context
• Having signed informed consent for participating in the study

Exclusion Criteria

• Contra-indication to MRI

• Cardiac pacemaker or defibrillator implant
• Neurosurgical clips
• Cochlear implants
• Intra-orbital or encephalic foreign bodies
• Stents implanted since less than 4 weeks and osteosynthesis equipment implanted since less than 6 weeks
• Claustrophobia
• Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
• Eye examination suggests a pre-existing eye abnormality that could affect the visual function (amblyopia, strong myopia…)
• Pregnant or breastfeeding women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Rennes

Rennes, , France

Countries

France

Other Identifiers

35RC17_8828_DTI et NOI

Identifier Type: -

Identifier Source: org_study_id