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

November 8, 2022 updated by: Rennes University Hospital
Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patient with Optic Neuritis
Device: MRI
MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study of DTI markers in the assessment of the visual prognosis at 6 months of an inflammatory NO based on RNFL thickness (< ou > 75 µm)
Time Frame: Month 6
MRI
Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study of DTI markers in the assessment of the visual prognosis at 6 months of an inflammatory NO based on visual acuity and/or sensible damage to the field of vision
Time Frame: Month 6
MRI
Month 6
Comparison of the structural anomalies detected in DTI to the standard morphological MRI (Coronal T2 Fat-Sat MRI and T1 Gadolinium) for ON
Time Frame: Month 6
MRI
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 4, 2017

Primary Completion (ACTUAL)

June 24, 2022

Study Completion (ACTUAL)

June 24, 2022

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

June 15, 2018

First Posted (ACTUAL)

June 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC17_8828_DTI et NOI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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