- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07560995
Internuclear Ophthalmoplegia and Multiple Sclerosis: a Multicenter Retrospective Study (INO&MS)
Internuclear ophthalmoplegia is a symptom frequently associated with multiple sclerosis (MS), although other etiologies are possible. Some patients do not meet the diagnostic criteria for MS at the time of the internuclear ophthalmoplegia episode but subsequently convert to MS. Studying this specific clinical situation may help enable earlier diagnosis of MS.
The objective is to analyze the proportion of patients with isolated internuclear ophthalmoplegia who convert to multiple sclerosis and to identify factors associated with this conversion.
The study hypothesis is that the presence of internuclear ophthalmoplegia is highly suggestive of multiple sclerosis, particularly when cerebrospinal fluid-specific oligoclonal bands are present.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kévin BIGAUT
- Phone Number: +33 3 88 12 60 96
- Email: kevin.bigaut@chru-strasbourg.fr
Study Contact Backup
- Name: Sebille COLIN
- Phone Number: +33 3 88 11 52 17
- Email: sebille.colin@chru-strasbourg.fr
Study Locations
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-
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Strasbourg, France, 67 200
- Les Hôpitaux Universitaires
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Contact:
- Kévin BIGAUT
- Email: kevin.bigaut@chru-strasbourg.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Patients with internuclear ophthalmoplegia listed as a primary or associated diagnosis
- Patients hospitalized in a neurology department
Exclusion criteria:
- Patients under 18 years of age
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Internuclear ophthalmoplegia
This is a retrospective cohort study involving patients who have experienced internuclear ophthalmoplegia.
For each patient, it is determined whether a diagnosis of multiple sclerosis was established or not.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analyze the proportion of patients with isolated internuclear ophthalmoplegia who convert to multiple sclerosis.
Time Frame: 1 year
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Proportion of patients with isolated internuclear ophthalmoplegia who converted to multiple sclerosis during follow-up.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kévin BIGAUT, Hopitaux universitaires de Strasbourg
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE-2025-86
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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