Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
NCT ID: NCT04860947
Last Updated: 2024-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2019-06-25
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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MS patients
Brain MRI
* Axial DWI with ADC card
* Axial 2D TSE T2/DP or 3DT2
* Gadolinium injection (0.1 mmol/kg)
* 3D Fluid-attenuated inversion recovery
* 3D T1 with Gadolinium injection.
Spinal Cord MRI
Sagittal T2 Sagittal T1 with Gadolinium injection
Retinal imaging
spectral-domain high definition optical coherence tomography
Interventions
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Brain MRI
* Axial DWI with ADC card
* Axial 2D TSE T2/DP or 3DT2
* Gadolinium injection (0.1 mmol/kg)
* 3D Fluid-attenuated inversion recovery
* 3D T1 with Gadolinium injection.
Spinal Cord MRI
Sagittal T2 Sagittal T1 with Gadolinium injection
Retinal imaging
spectral-domain high definition optical coherence tomography
Eligibility Criteria
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Inclusion Criteria
* The patient must have given their informed and signed consent.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least (≥)18 years old.
* The patient has experienced a CIS, has currently a RRMS or progressive MS with:
* Less than 10 years of disease duration;
* With or without DMD;
* EDSS score 0 - 7.0.
Exclusion Criteria
* The patient is under judicial protection.
* The patient refuses to sign the consent.
* It is impossible to correctly inform the patient (Inability to understand the study, language problem).
* The patient is pregnant or breast-feeding.
* Patient has a bilateral optic neuritis or other significant ophthalmological antecedent.
* Patient with MRI contra-indications.
* patient has a contraindication to gadolinium injection
* The patient has bilateral optic neuritis or other significant ophthalmological antecedent
* Patient is having a relapse or has had a relapse in the last 3 months
* The patient has a severe psychiatric illness
* The patient has severe chronic alcoholism
18 Years
ALL
No
Sponsors
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Institut de Recherches en Biothérapie
UNKNOWN
Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Eric Thouvenot
Role: PRINCIPAL_INVESTIGATOR
CHU Nimes
Locations
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CHU de Nimes
Nîmes, , France
Countries
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Other Identifiers
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2018-A03152-53
Identifier Type: OTHER
Identifier Source: secondary_id
CIVI/2018/ET-01
Identifier Type: -
Identifier Source: org_study_id
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