Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03570385
Recruitment Status : Active, not recruiting
First Posted : June 27, 2018
Last Update Posted : December 14, 2021
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?

Condition or disease Intervention/treatment Phase
Optic Neuritis Device: MRI Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Interventional pilot study with minimal risks and constraints, descriptive, prospective, monocentric
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : April 4, 2022
Estimated Study Completion Date : April 4, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Patient with Optic Neuritis Device: MRI
MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570385


Locations
Layout table for location information
France
CHU de Rennes
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03570385    
Other Study ID Numbers: 35RC17_8828_DTI et NOI
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases