ClinicalTrials.gg
RecruitingNCT04448938RESONANCEUpdated Jan 5, 2026

RESting-state Functional MRI in Patients With Optic Neuritis for ANticipation of reCovEry

An observational study in Neuritis, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Started Dec 2020; still recruiting 5 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

When patients arrive in the waiting room of the MRI department, patients will be given the briefing note explaining the purpose of the study and how it is going. During the consultation, the radiologist will check the inclusion and non-inclusion criteria, and will take the time to answer all of the patient's questions about the study. If the patient agrees to participate in the research, the investigating doctor will obtain his consent.

The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional sequence of f-mRI, called resting state, and performed before injection of gadolinium contrast agent.

A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe de Rothschild Foundation. During this visit, an OCT examination (optical coherence tomography), a visual field as well as the measurement of visual acuity will be carried out, in accordance with the treatment usually practiced at the Adolphe de Rothschild Foundation.

The subjects of the control group who agreed to participate will benefit from an MRI examination which will include, in addition to the sequences planned for these patients according to their indications, the two non-injected sequences which will be performed on patients with suspected NO.

The possible existence of visual problems in the subjects of the control group will also be asked to them by interrogation. No eye exams or follow-up visits are planned, and control group participation will end after the MRI scan.

Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and the measurement of visual acuity will be performed. This visit and the examinations carried out correspond to the usual care of patients suffering from NO and followed at the Adolphe de Rothschild Foundation Hospital.

02

Conditions studied

  • Neuritis

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03

In context

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

This study's planned enrollment of 200 is above the median of 123 across 20 observational studies indexed under Neuritis.

Browse Neuritis studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with clinical suspicion of NO who must perform an MRI for the diagnosis of NO. A control group will also be set up to compare the visual functional networks of patients with NO with those of a sample of subjects free from NO.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients over 18 years of age
  • Clinical suspicion of optic neuritis
  • Benefiting from an MRI for exploration of optic neuritis
  • Affiliate or beneficiary of a social security scheme
  • Having received informed information about the study and having given their express consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • to absolute or relative MRI (in particular, pregnant or breastfeeding women)
  • History of amblyopia
  • Any pre-existing pathology leading to a decrease in vision (e.g. retinitis pigmentosa, AMD, etc.)
  • Patient benefiting from a legal protection measure
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • optic neuritis

    Other: MRI · Other: visual acuity

  • control

    Other: MRI

Interventions

  • OtherMRI

    The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional sequence of f-mRI, called resting state, and performed before injection of gadolinium contrast agent. A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe de Rothschild Foundation. The subjects of the control group who agreed to participate will benefit from an MRI examination which will include, in addition to the sequences planned for these patients according to their indications, the two non-injected sequences which will be performed on patients with suspected NO.

  • Othervisual acuity

    Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and the measurement of visual acuity will be performed. This visit and the examinations carried out correspond to the usual care of patients suffering from NO and followed at the Adolphe de Rothschild Foundation Hospital

06

What researchers measure

Primary outcomes

  1. The ophthalmological functional recovery will be assessed by measuring the low contrast visual acuity on the Early Treatment Diabetic Retinopathy study scale (ETDRS scale).

    ETDRS charts presents a serie of 70 letters. The visual acuity letter score is equal to the total number of letters read correctly at 4.0 m. The score ranged to 20/10 (best visual acuity) to 20/20 000 (worst visual acuity).

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2020 (actual). Primary completion is estimated for Dec 2026, 72 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2020
First posted
Jun 26, 2020
StartActual
Dec 17, 2020
Primary completionEst.
Dec 2026
CompletionEst.
Jun 2027
Last update
Jan 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04448938
Responsible party
Sponsor
First posted
Jun 26, 2020
Start date
Dec 17, 2020
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jan 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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