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

Primary Purpose

Optic Neuritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Optic Neuritis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with Optic Neuritis

Arm Description

Outcomes

Primary Outcome Measures

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)
MRI

Secondary Outcome Measures

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
MRI
Comparison of the structural anomalies detected in DTI to the standard morphological MRI (Coronal T2 Fat-Sat MRI and T1 Gadolinium) for ON
MRI

Full Information

First Posted
November 9, 2017
Last Updated
November 8, 2022
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03570385
Brief Title
Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
Acronym
DTI et NOI
Official Title
Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional pilot study with minimal risks and constraints, descriptive, prospective, monocentric
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with Optic Neuritis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)
Primary Outcome Measure Information:
Title
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)
Description
MRI
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
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
Description
MRI
Time Frame
Month 6
Title
Comparison of the structural anomalies detected in DTI to the standard morphological MRI (Coronal T2 Fat-Sat MRI and T1 Gadolinium) for ON
Description
MRI
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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