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Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia (HYPER-III)

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ClinicalTrials.gov Identifier: NCT03135574
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of consultation in ophthalmology.

It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In the usual clinical practice, the investigators noticed in several patients unusual areas of high-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the investigators, has never been reported in the literature and could confirm the nerve impairment.

In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be systematically included in the usual MRI protocol.


Condition or disease Intervention/treatment
Ophthalmoplegia Diagnostic Test: MRI T2 sequence of the oculomotor tract

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia
Actual Study Start Date : April 16, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Intervention Details:
  • Diagnostic Test: MRI T2 sequence of the oculomotor tract
    Patients with ophthalmoplegia will benefit from an MRI T2 sequence of the oculomotor tract (additional time of 4 minutes).


Primary Outcome Measures :
  1. High-intensity signal of the oculomotor nerve on MRI T2 sequence (presence or absence, determined by a radiologist) [ Time Frame: Baseline ]

    High-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment).

    High-intensity signal on T2 MRI sequence is defined as a signal area which is more intense than the contralateral nerve or more intense than the white matter signal.

    A double separate reading of the imaging will be carried out by an experienced radiologist and a junior radiologist on anonymized MRIs, with no access to clinical elements and interpretation of the other radiologist. In case of discrepancy between the radiologists, the final decision will be made by a third experienced radiologist under the same conditions (no access to clinical data, no access to the other evaluations).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients (18 years of age or older) benefiting from an MRI, requested by the ophthalmologist for an assessment of an ophthalmoplegia.
Criteria

Inclusion Criteria:

  • Ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or progressive onset)

Exclusion Criteria:

  • Absolute contraindication to MRI or injection of contrast agents

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): NCT03135574


Contacts
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Contact: Laurence Salomon, MD PhD 148036431 ext 0033 lsalomon@for.paris
Contact: Françoise Héran-Dreyfus, MD 148037406 ext 0033 fheran@for.paris

Locations
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France
Fondation Ophtalmologique A. de Rothschild Recruiting
Paris, France, 75019
Contact: Françoise Héran-Dreyfus         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03135574     History of Changes
Other Study ID Numbers: FHN_2016_27
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations
Eye Diseases
Signs and Symptoms