Optic NeuritisDTI et NOINCT03570385
Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
A study testing MRI in people with Optic Neuritis, run by Rennes University Hospital at 1 site in France.
Trial summary
Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)? Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2017to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?
- Conditions
- Optic Neuritis
- Being tested
- MRI
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)
| Study group | Role | What they receive |
|---|---|---|
| Patient with Optic Neuritis | Experimental | Not described Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 6
Secondary outcomes (2)
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
Measured: 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
MRI
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start4 Dec 2017
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional pilot study with minimal risks and constraints, descriptive, prospective, monocentric
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570385
- Sponsor's protocol ID
- 35RC17_8828_DTI et NOI
- Acronym
- DTI et NOI
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2017
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?
- ClinicalTrials.gov ID
- NCT03570385
- Acronym / sponsor ID
- DTI et NOI / 35RC17_8828_DTI et NOI
- Conditions
- Optic Neuritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional pilot study with minimal risks and constraints, descriptive, prospective, monocentric
| Arm | Type | Receives |
|---|---|---|
| Patient with Optic Neuritis | Experimental | Device: MRI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- Contra-indication to MRI
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI in diffusion tensor (DTI : Diffusion Tensor Imaging) | Device | Patient with Optic Neuritis |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Optic Neuritis, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.